| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01283-1 |
| Product Name/Description |
Sorin Perfusion System - S5/C5 Heart Lung Machine
S5 Roller Pump
Product Code: 10-80-00
Multiple Serial Numbers
S5 Double Roller Pump
Product Code: 10-85-00
Multiple Serial Numbers
S5 Control Panel for Mast Roller Pump 150
Product Code: 28-95-80
Serial#: 50E60933, 50E60951 and 50E60946
Pump Control Panel (CP5)
Product Code: 60-02-60
Serial #: 60E10351 and 60E10353
ARTG Numbers: 108387, 94208 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
03 9799 7444 - Cellplex |