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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00188-1
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 Australia Pty Ltd
Reason/Issue	The distal pressure sensor calibration may have drifted and require re-calibration. The following error codes may be displayed during set up or infusion on the affected devices: E180/N180, E181/N181, E186/N186, E187/N187, E346. If distal pressure sensor drift occurs, the pump may not sense the build up of pressure and will not alarm when occlusion thresholds are exceeded.
Recall Action	Recall for Product Correction
Recall Action Instructions	Hospira is providing end users with instructions to determine if they are affected by the issue. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Hospira is also in the process of evaluating the design of the distal pressure sensor to reduce the opportunity for pressure sensor drift. Additionally, a yearly test to determine if the distal pressure sensor’s calibration has drifted will be released in 2013.
Contact Information	1300 046 774 (Option 1) - Hospira Customer Service