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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00788-3
Product Name/Description Keypad of Alaris LVP module (Component of a general purpose infusion pump); Module Model: 8100

Part number: TC10005926

Manufactured between: 5 October 2011 to 9 February 2012

Multiple Serial Numbers

ARTG Number: 146664
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/08/2012
Responsible Entity CareFusion Australia 316 Pty Ltd
Reason/Issue Alaris Pump module model 8100 that contains the door assembly with keypad part number TC10005926 may be at risk of the door keypad overlap separating from the keypad assembly. When the Pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.
Contact Information 02 9624 9013 - CareFusion Regulatory Affairs