MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-29 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-90411 manufactured by Thoratec Switzerland Gmbh.
[179450435]
Multiple attempts for this information were made however no response was 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
[179450436]
It was reported that a centrimag unit being used for vv ecmo was stopping intermittently and had to switch to the backup unit. Revolutions per minute(rpms) went to 0 with 0 flows and immediately increased back to the set value of 5500. This happened again within a few minutes. The motor was not spinning during both incidents. Patient's spo2 (oxygen saturation) decreased to the 80's briefly. The doctor switched to the backup system. Patient's heart rate briefly decreased to the 40's. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00291 |
| MDR Report Key | 9644127 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-11 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Model Number | 201-90411 |
| Catalog Number | 201-90411 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-29 |