All Plum A+/A3+ Family of Infusers (February 07, 2013)

Starting date:

February 07, 2013

Posting date:

February 07, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-39701

• Reason
• Affected products

Reason

Possible interruption of therapy may occur while using a Plum A+/A+3 Infuser. The 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 8 hours.

Potential for the Distal (Occlusion) Pressure Sensor Pin to break on Plum A+ Infusers.

Hospira received reports related to Distal Pressure Sensor Calibration Drift on Plum A+ Infusers. If the Distal Pressure Sensor Calibration Drifted, it will need to be recalibrated. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, user may expericence Nuisance (False) Digital Occlusion Alarms or Distal Occlusions that may not be detected. These errors invoke Visual and Audible warnings to the users.

Potential for the Plum A+ fluid shield to inadequately prevent fluid from entering into the Plum A+ device (Fluid ingress) and potentially causing damage to the pumping mechanism and/or sensors.

If the Plum A+ fluid shield diaphragm is out of specification, it may cause N250 "door open while pumping" or N100 "unrecognizable cassette" alarms. Both the N250 and N100 alarm conditions trigger an audible and visual warning to the user, which may occur during setup, infusion or Performance Verification Testing (PVT).

Affected products