Sorin Perfusion System - S5/C5 Heart Lung Machine 의 리콜

Recall

RC-2013-RN-01283-1

Class I

2013-12-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01283-1

The manufacturer, sorin group deutschland gmbh has received reports of some malfunctioning em1 model shaft encoders in the pumps. the encoder housing can be exposed to excessive traction resulting in the speed encoder becoming non-responsive and displaying an error message "shaft angle encoder fault". this fault results in the encoder code wheel coming in contact with the silicone detector cover and drawing out the silicon material from the detector housing. if the pump module has to be replaced and the perfusionist is not able to maintain the blood flow within 3 minutes, the situation may lead to oxygen under supply. it may be necessary to hand crank the pump or operate the cp5 manually in case of a pump control failure.

Cellplex is advising users that the affected pumps should not be used as an arterial pump. Prior to the use of the affected pumps, users are advised to rotate the speed encoders to ensure that complete smooth transition occurs. If there is excessive traction, DO NOT use the pump. Cellplex is advising that all affected pumps used as arterial pumps will be replaced by loan pumps until the correction is performed. All affected units will be corrected by Cellplex.