MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-05 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-30300 manufactured by Thoratec Switzerland Gmbh.
[179790317]
The device is expected to be returned for evaluation. It has not yet been received. The centrimag motor associated with this event is being reported under mfr # 2916596-2020-00551. No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[179790318]
It was reported that there was rapid motor deterioration, and a whirring sound was emitted from the device. The console screen then went black and the motor failed. After a few seconds the console rebooted but the decision was made to exchange the entire unit. When the pump head was removed it was noted that the motor was extremely hot. The pump was inserted into a new motor and console. During this exchange the patient experienced mild desaturation but there was no haemodynamic compromise due to the quick exchange of the pump. There were no alarms reported for the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00550 |
| MDR Report Key | 9673915 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC SWITZERLAND GMBH |
| Manufacturer Street | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-8005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-05 |
| Model Number | 201-30300 |
| Catalog Number | 201-30300 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |