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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