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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
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:
- Attachment 1: Symbiq Infusion pumps Device Field correction Listing
- Attachment 2: PLUM Infusion pumps Device Field correction Listing
- Attachment 3: Lifecare PCA Infusion pumps Device Field correction Listing.
- Attachment 4: Gemstar Infusion pumps Device Field correction 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 |
|
Symbiq white screen/Unrestricted flow/Air in line |
Symbiq pumps (List 16026/16027)
with Software 3.21, |
Potential risk: delay in therapy, overinfusion, air embolism. |
Use error when removing cassette and software related |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Piezo electric assembly | All PLUM A+/A+3 pumps |
Failure of audible alarm.
Potential risk: delay in therapy. |
Manufacturing defects |
|
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 |
|
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. |
|
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:
|
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 |
|
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 |
|
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 |
|
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. |
|
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 |
|
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 |
|
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. |
|
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 |
|
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. |
|
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:
|
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. |
|
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 |
|
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. |
|
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 |
|
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 |
|
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 |
|
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 |
|
*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.