MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for CENTRIMAG MOTOR, US 102953 manufactured by Thoratec Switzerland Gmbh.
[184666988]
No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[184666989]
The site switched the centrimag pump due to a battery failure on the console. The locking screw was reported to not be properly threaded on back of pump. The patient was switched to a second back up pump. The centrimag pump was clamped twice prior to switch. The patient tolerated the equipment swap well. Related manufacturer number: 2916596-2019-05341.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00811 |
| MDR Report Key | 9856776 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MOTOR, US |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | KFM |
| Date Received | 2020-03-19 |
| Model Number | 102953 |
| Catalog Number | 102953 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-19 |