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 2020-02-24 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-30300 manufactured by Thoratec Switzerland Gmbh.
[182996121]
The associated centrimag 2nd generation primary console, sn: (b)(4) is reported under mfr # 2916596-2020-00891, and the associated centrimag motor, ous, sn: (b)(4) is reported under mfr # 2916596-2020-00892. The device is expected to be returned for evaluation. It has not yet been received. 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
[182996122]
It was reported that there was an s3 alert on the console while the system was in use on a patient in an ambulance en-route to the hospital. There was also no flow probe reading. The back-up console was attached and initially got a reading. However, then the same s3 alert appeared and the flow probe did not have a reading. The device was detached from the ambulance power supply and turned off and on. Following that the flow probe worked fine for the duration of the journey. There were no adverse patient effects. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00893 |
| MDR Report Key | 9748445 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-08-10 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-24 |
| 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 2ND GENERATION PRIMARY CONSOLE |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-24 |
| Model Number | 201-30300 |
| Catalog Number | 201-30300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-24 |