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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01216-1
Product Name/Description Advanced Perfusion System 1 (heart-lung bypass machine)

Product Code: 801764

Batch Numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027 & 1100-1429

ARTG Number: 93976
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/11/2012
Responsible Entity Terumo Australia Pty Ltd
Reason/Issue The manufacturer has received five reports between 2003 and 2012 of spontaneous power loss to the Terumo System 1. In all reports the systems lost full power and did not switch to battery backup without warning. In one report the system re-booted automatically after about 30 seconds and in the remaining reports the system regained power after toggling the main power switch. In all of the reports the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.
Recall Action Recall for Product Correction
Recall Action Instructions An update to the instructions for use (IFU) is being issued to customers as an interim measure and the manufacturer's investigation into the root cause investigation is ongoing. Terumo is advising that should the investigation conclude that a corrective action is necessary, users will be notified.
Contact Information 02 9878 5122 - Terumo Regulatory Affairs