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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00190-1
Product Name/Description	All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet Software Plum A+Single Channel Infusion Pump Catalogue Number: 611239101 Number on Pump: 12391 & 11971 Plum A+ Infusion Pump with MedNet Software Catalogue Number: 612079201 Number on Pump: 20792 Plum A+3 Infusion Pump with MedNet Software Catalogue Number: 612067801 Number on Pump: 20678
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/02/2013
Responsible Entity	Hospira Pty Limited
Reason/Issue	There is the possibility of interruption to therapy which may occur when an E321 error code occurs while using a Plum A+/A+3 infuser. The E321 error code occurs when the A+/A+3 infuser is operating on AC power and the software detects that the battery could not be fully charged within eight hours. The root cause of this issue is a degraded battery. The error code is accompanied by both an audible alarm and a visual error message on the infusers display.
Recall Action	Recall for Product Correction
Recall Action Instructions	Hospira has provided work around instructions in the customer letter to identify and mitigate the issue temporarily. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in therapy could result in significant injury or death. Hospira will be deploying a new battery that will mitigate the potential risk of interruption of therapy due to E321 error codes.
Contact Information	1300 046774 (Option 1) - Hospira Customer Service