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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00180-1
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	The Plum A+ fluid shield diaphragm may be out of specification and cause N250 "door open while pumping" or N100 "unrecognisable cassette" alarms. Hospira Inc have advised that these alarms invoke audible and visual warnings to the user which may occur during setup, infusion or Performance Verification Test and will cause the device set up to be interrupted or the infusion to stop. If these alarms occur whilst the clinician is setting up the pump or an infusion is in progress, a delay or interruption in therapy may result
Recall Action	Recall for Product Correction
Recall Action Instructions	If the unrecognisable cassette alarm occurs during the loading process prior to infusion starting, remove the cassette and attempt to reload the cassette again. If the alarm happens multiple times it is recommended to get a new tubing set or remove the device from service. To correct this issue, Hospira has implemented a screening process to identify fluid shields that are out of specification. Plum devices shipping from Hospira since September 2012 have diaphragms that have been screened for the undersized dimension. Hospira will be contacting customers to arrange for screening and replacement of impacted fluid shields.
Contact Information	1300 046 774 ( Option 1) - Hospira Customer Service