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Health professional risk communication

Hospira Infusion Pumps - Important Medical Device Safety Information - Notice to Hospitals

Starting date:
March 15, 2013
Posting date:
March 18, 2013
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-26209

This is duplicated text of a letter from Hospira Healthcare Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Hospira Infusion Pumps

March 15, 2013

To: Risk management/Biomedical engineering

Please distribute to all relevant Departments, other involved professional staff, and any others for whom this information is relevant and post this NOTICE in your institution.

Subject: Important Medical Device Safety Information for Hospira infusion pumps

  • Symbiq (List # 16026, 16027)
  • Plum (List # 11005, 12391, 12618, 20678, 20679, 20792, 11555, 11781, 11845, 11846, 11859)
  • Lifecare PCA (List # 01950, 12384, 20709)
  • Gemstar (List # 13000, 13150, 13087, 13088)

Hospira Healthcare Corporation, in collaboration with Health Canada, is providing this important information to make you aware of potential safety issues that you may experience with Hospira Symbiq, Plum, Lifecare PCA, and Gemstar infusion pumps. Following a global assessment of these infusion devices to retrospectively assess complaint trends or quality issues, we have identified and communicated a number of Device Field corrections. This Notice to Hospitals is being issued in order to emphasize recommendations and safety instructions required by providing a summary of all ongoing field corrections and their corresponding root causes. These issues are summarized in the attached table of this notice.

Additionally, Hospira has voluntarily stopped all new sales of its intravenous infusion pumps, except in a priority situation involving patient safety, while it addresses issues in its quality management system.

  • Risks associated with each Device Field correction are detailed in the tables attached per pump family (Symbiq, Plum, LPCA and Gemstar).
  • Health professionals are required to follow the instructions detailed in the Device Field correction letters and summarized in the tables attached.
  • Hospira will be contacting all customers to initiate field remediation as soon as corrective actions are finalized and available for field deployment.
  • If you have further distributed or discharged these pumps to other facilities/locations or patients, please disseminate this communication appropriately, and follow up with patients who experience problems with these pumps accordingly.

Please complete the attached customer reply form* and return it to Hospira Healthcare Corporation by either fax (1-877-906-0208) or email canadarecall@hospira.com. If you have further distributed the Symbiq, Plum, LPCA and Gemstar Infusers, please notify your accounts who may have received these infusers from you and ask them to complete the reply form.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents involving Hospira infusion pumps should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

Hospira Healthcare Corporation
1111 Dr.Frederik-Philips Blvd. Suite 600
Saint-Laurent (Quebec) H4M 2X6

Contact Hospira Healthcare Corporation
Hospira Contact Contact Information Areas of Support
Canadian Service Center 1-866-488-6088 Option 5/2,
CanadaPumpSupport@hospira.com
To report adverse events or product complaints
Hospira Clinical Support 1-866-488-6088 Option 4, mail-
ClinSupport@hospira.com
For Clinical Assistance

To correct your mailing address or fax number, contact Hospira Healthcare Corporation.

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

original signed by

Rania Al-Ammar
Regional Director, Commercial Quality

References:

  1. Attachment 1: Symbiq Infusion pumps Device Field correction Listing
  2. Attachment 2: PLUM Infusion pumps Device Field correction Listing
  3. Attachment 3: Lifecare PCA Infusion pumps Device Field correction Listing.
  4. Attachment 4: Gemstar Infusion pumps Device Field correction Listing
Attachment 1: Symbiq Infusion pumps; Open Device Field Corrections Listing
Field correction description Device List number or Software version impacted Description of the issue and safety risk associated Cause Recommended actions
Symbiq AC power cord Symbiq pumps (List 16026/16027) with Software 3.21/3.12, The plastic around the power cord might exhibit damage.

Potential risk: overheating, burning and electrical fire.

significant damage over time, due to excessive mechanical stress
  • Inspect cords prior to operating the device.
  • Discontinue use of any damaged cords.
Symbiq white screen/Unrestricted flow/Air in line Symbiq pumps (List 16026/16027)

 with Software 3.21, 

  • White screens appearing at the pump start-up
  • Potential for unrestricted flow.
  • Symbiq infusion pumps not detecting air in line at the end of an infusion.

Potential risk: delay in therapy, overinfusion, air embolism.

Use error when removing cassette and software related
  • Use proper technique for removing the Symbiq cassette from the pump in order to prevent occurrence of unrestricted flow.
  • Avoid over programming the volume to be infused with the intention of using the "Air in Line" alarm to alert the clinician to the end of an infusion.
Symbiq touchscreen issue (all Symbiq pumps) All Symbiq pumps, (List 16026/16027) Touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user.

Potential risk: delay in therapy, incorrect therapy.

software related
  • If a failure to respond is noted, remove the device from service and send to Biomed for screen recalibration. 
  • Visually confirm desired entries prior to initiating infusions.
White screen during KVO titration Symbiq pumps (List 16026/16027) with Software 3.12/3.13/3.22,  White screen leading to pump shutoff during KVO titration.

Potential risk: delay in therapy.

software related
  • Ensure VTBI have a non-zero value when programming KVO
  • Refrain from pressing. NEXT/START until VTBI and time values are set.
White screen due to hardware module (SOM2) All Symbiq pumps, (List 16026/16027) White screen leading to pump shutoff at start-up or during infusion.

Potential risk: delay in therapy.

Design issue affecting some SOM2 boards/modules
  • If a white screen occurs, manually eject the cassette as per the Symbiq instruction manual.
  • Remove pump from service and return for repair.
Proximal occlusion alarms that cannot be cleared All Symbiq pumps, (List 16026/16027) False proximal occlusion alarms which cannot be cleared by the clinician.

Potential risk: delay in therapy.

Unexpected interaction between the Symbiq proximal occlusion sensing subsystem and the administration set
  • If the device continues to indicate proximal occlusion after appropriate clinical steps are taken, remove from use and send for repair.
Malfunction S205: Backup Battery Failure Symbiq pumps with software 3.13, (List 16026/16027) Backup Battery Failure alarms (S205) might occur in some Symbiq v3.13 pumps.

Potential risk: The S205 alarm does not stop the pump, or interfere with the infusion thus risk of patient harm is highly unlikely. 

This error is related to an installation issue with components on some of the Power Supplier Controller (PSC) Boards
  • If an S205 alarm is observed remove pump from service and return for repair.
Attachment 2: PLUM Infusion pumps; Open Device Field Corrections Listing (1/2)
Field correction description Device List number or Software version impacted Description of the issue and safety risk associated Cause Recommended actions
Potential for fluid ingress All PLUM XL pumps Failure of audible alarm.

Potential risk: delay in therapy.

Electrical short between pins due to contamination of the surface ("buzzer") caused by fluid ingress
  • Perform Alarm Tests Prior to Each Clinical Use (during your pump cleaning process).
  • Follow Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventive maintenance.
Piezo electric assembly All PLUM A+/A+3 pumps Failure of audible alarm.

Potential risk: delay in therapy.

Manufacturing defects
  • Test the alarm volume capability prior to each use.
  • Report any alarm failures and return pump for repair.
Flow Regulator Closer All PLUM A+/A+3 pumps The regulator closer does not close the flow regulator actuator completely when door is opened.

Potential risk: Unrestricted flow.

Incorrect manufacturing process
  • Close all slides clamps or roller clamps prior to opening the door.
  • Report any failures related to the regulator closer and return pump for repair.
Continuous recycling and/or rebooting All PLUM A+ (with Mednet software version 13.40) Continuous recycling and /or rebooting during start up of device.

Potential risk: delay in therapy.

Software timing issue at start up. 
  • Ensure that contrast and/or brightness settings are set to default levels.
  • Report any failures related to the continuous recycling and/or rebooting, and return pumps for repair.
Audio level rotary knob Plum A+ single channel The volume control knob on some infusers may function differently than described in the System Operating Manual (i.e., clockwise may decrease instead of increase volume).

Potential risk: delay in therapy.

Layout of the volume knob was rotated 180 degrees on the peripheral PWA Circuit Board Confirm that the audible alarm volume is acceptable for the environment where the infuser will be used prior to clinical use.

To determine which direction to turn the knob, to change and confirm the volume level, follow the directions below:

  • Turn the pump on with a cassette installed.
  • Look at the infuser display until the "Cassette test in progress" message is shown.
  • During the cassette test, open the cassette door. The pump will alarm.
  • Adjust the volume to the desired level, rotating the volume control knob (located on the back of the infuser), until the audible volume is acceptable, then close the cassette door.
Attachment 2: PLUM Infusion pumps; Open Device Field Corrections Listing (2/2)
Field correction description Device List number or Software version impacted Description of the issue and safety risk associated Cause Recommended actions
Door Roller All Plum A+/A+3 pumps The door roller assembly has the potential to break.

Potential risk: unrestricted flow and/or over delivery.

Customer use, Door roller material and design
  • Visually inspect the door roller axel for any damage or misalignment.
  • If damage confirmed, take the device out of service and return for repair.
Fluid shield-Fluid ingress All Plum A+/Plum A+3 Shield might not prevent fluid from entering into device causing damage to the pumping mechanism and/or sensors.

Potential risk: delay in therapy.

Fluid ingress resulting from incorrect cleaning methods
  • Clean the device in accordance with the instructions in the PLUM manual.
  • Report any abnormal error codes and return pump for repair.
Battery Charging Timed Out All Plum A+/Plum A+3 E321 error code occurs when the Plum A+/A+3 infuser is operating on AC power and the software detects that the battery could not be fully recharged within eight hours.

Potential risk: delay in therapy.

Variability in battery performance. Degraded battery that can no longer be fully charged
  • Report any pumps displaying error 321 after a complete charging cycle.
  • Replace the battery as per the instructions in the PLUM manual.
Fluid Shield Diaphragm All Plum A+/Plum A+3

(pumps shipped before September 2012)

N250 "Door Open while pumping" or N100 "Unrecognizable Cassette" alarms during set-up, infusion or PVT.

Potential risk: delay in therapy.

Fluid shield diaphragm may be out of specification due to undersized parts.
  • When N250/N100 error is detected, remove the cassette and reload it as per instructions in the PLUM manual.
  • If reloading fails, return pump for repair.
Distal Occlusion-Pressure Sensor Drift All Plum A+/Plum A+3 Distal occlusions that may not be detected or nuisance (false) distal occlusion alarms.

Potential risk: delay in therapy, underdelivery or overdelivery.

Pressure sensor calibration drift
  • If you receive atypical reports of error codes related to calibration drift, remove pump from service and perform a PVT Distal occlusion test.
  • If PVT fails, return pump for repair.
Broken Distal Occlusion Pressure Pin All Plum A+/Plum A+3 Incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.

Potential risk: delay in therapy, underdelivery or overdelivery.

Incorrect insertion of the cassette during use can break distal pin, pin design
  • Visually inspect for broken/damaged distal pin. Return pump for repair if necessary.
  • Insert cassette into the pump in accordance with the instructions in the PLUM manual.
Attachment 3: Lifecare PCA Infusion pumps; Open Device Field Corrections Listing
Field correction description Device List number impacted Description of the issue and safety risk associated Cause Recommended actions
Improper use of the side clamp All LPCA pumps Failure to close the slide clamp when the syringe (vial) was manipulated or when stopping infusion during the delivery of fluids. 

Potential risk: over delivery.

Use error during vial manipulation, difficulty loading the syringe especially seating the injector, insufficient training in the critical environment, bar code not easily read, reluctance to disconnect tubing from the patient to avoid contamination of injection site.
  • Follow the labeled instructions for proper use of the slide clamp when manipulating the syringe (vial) or when stopping infusion during delivery of fluids.
Door Tampering LPCA pumps (List 12384,20709) The door can be flexed to the point which allows unauthorized personnel to receive an un-prescribed bolus of medication.

Potential risk: patient might receive more medication than intended.

User attempt to flex door when closed
  • Tampering should be suspected if a check vial or check injector alarm occurs when the door is closed and in the locked position.
  • Tampering should also be suspected if the vial or the injector has been dislodged from the cradle unexpectedly.
  • Additionally, a review of the device's history logs may aid in the confirmation of a tampering event.
  • If customer suspects an instance of tampering has occurred, contact Hospira to report the issue and return the pump for service.
E630 Screw Rotation Error LPCA pumps (List 12384,20709) manufactured or serviced between May 2010 & Sept.2012 Motors may cause an error code 630 (screw rotation error) at certain delivery rates.

Potential risk: delay in therapy.

Incorrect component/changes made by supplier on components. 
  • If you experience an E630 error turn the pump off by pressing the On/Off key and then turn it back on by pressing the On/Off key again.
  • If the error appears again, remove the pump from service and contact Hospira.
Undetected Distal Occlusions Caused by a Worn Half Nut All LPCA pumps Failure to detect distal occlusions.

Potential risk: delay in therapy.

Wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) preventing it from properly detecting the pressure build-up associated with a distal occlusion. Inspect your PCA devices as follows:
  • Perform the Performance Verification Test (PVT) Occlusion Test as defined in the PCA Technical Service Manual (TSM).
  • If the device does not pass this test, Remove pump from service and return for repair.
  • Perform the appropriate troubleshooting and repair activities defined by your facility, which may include in returning the device to Hospira for further servicing.
  • increase frequency of the occlusion test PVT to annual.
Attachment 4: Gemstar Infusion pumps and accessories; Open Device Field Corrections Listing (1/2)
Field correction description Device List number impacted Description of the issue and safety risk associated Cause Recommended actions
Gemstar Lithium Battery - Low Voltage All Gemstar pumps 11/004 error will be displayed and the device will not be able to be used.

Potential risk: delay in therapy.

Lithium battery has exceeded its expected life.
  • Lithium batteries that are older than 3 years should be replaced.
Gemstar battery leakage All Gemstar pumps Damage from  Gemstar Battery Leakage May Cause the Device to Shut Off Without Warning.

Potential risk: delay in therapy.

Corrosion due to AA battery leakage and voltage surge
  • The internal AA batteries and battery compartment should be inspected for signs of leakage, corrosion or other damage prior to each use. 
  • If a device exhibits damage caused by leaking batteries, immediately remove it from clinical service and return for repair.
Gemstar Pressure Sensor Calibration Drift Gemstar pumps manufactured or serviced after January 2009 The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, and missed or false alarms.

Potential risk: delay in therapy, overdose (due to bolus after occlusion).

Ineffective protective layer against elevated temperature and moisture.
  • Perform proximal and distal occlusion tests, as defined in the GemStar Technical Service Manual (TSM).
  • If the device fails either of the tests remove from use  and arrange for the return of your device for recalibration.
  • Add the performance of a proximal and distal occlusion test to your yearly GemStar maintenance schedule.
Gemstar Backward Motor Movement (X09/001 error) All Gemstar pumps the motor assembly may rotate backwards capturing additional medication that will be delivered.

Potential risk: Over infusion, delay in therapy.

Poor plastic clutch retainer performance
  • If your GemStar device displays an X09/001 error immediately remove it from clinical service and arrange for return of the device for repair.
Attachment 4: Gemstar Infusion pumps and accessories; Open Device Field Corrections Listing (2/2)
Field correction description Device   List number impacted  Description of the issue and  safety risk associated Cause Recommended actions
Gemstar Docking station-sparking/charring All Gemstar Docking stations List # 13075 Sparking, smoking, charring and shock have been reported when using the GemStar Docking Station.

Potential risk: electrical shock.

Fluid ingress due to the design of the docking station
  • Do not hang or place fluid containers over the docking station where they could leak fluid on the device.
  • Do not spray fluid, such as cleaning solution, directly on the docking station.
  • Clean the docking station using a damp cloth.
Gemstar Docking station - Missing cord retainer Gemstar Docking stations

Lots # 180025Q, 190025Q, 190035Q, 190045Q, 190065Q, 200095Q, 200105Q, 210015Q, 210025Q, 210035Q

Certain lots were manufactured without a cord spacer within the power cord retainer.

Potential risk: , there is no performance or safety hazard as a result of this issue.

Inadequate manufacturing documentation
  • Contact Hospira to initiate replacement of the impacted docking stations currently at your facility.
Gemstar Bolus cord- All Gemstar bolus cords (list 13027) Potential of Bolus delivery failures when using the Gemstar Bolus Cord.

Potential risk: unrequested bolus/failure to deliver.

Excessive damage of bolus cord
  • Care should be taken when removing the bolus cord from the base of the GemStar unit
  • Visually inspect cords, do not use cords if damaged.
  • When possible, Hospira recommends the use of the bolus push button on the pump.

*To contact Hospira Healthcare Corporation or to request a customer reply form, please call 1-866-488-6088 (toll free) or email canadarecall@hospira.com.