Recall Z-1325-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group Deutschland GmbH
S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
| Date | Mar 29, 2012 (initiated Feb 23, 2012) |
| Status | Terminated |
| Reason | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
| Root cause | Nonconforming Material/Component |
| Action | Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a |
| Quantity | 719 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jul 6, 2007 |