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 2019-04-19 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-30300 manufactured by Thoratec Corporation.
[142483858]
Approximate age of device: currently unavailable, will be updated upon manufacturer investigation conclusion. 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
[142483859]
The patient was being supported with a ventricular assist device for acute support. It was reported that the centrimag console went "blank" and that a drop in the rotations per minute (rpm) was indicated on the remote screen. The account also stated that a "no blood flow" notification appeared during the event. A reduced blood flow was noted on a separate monitoring device; the account expressed that this was the second time this situation had been observed, but with different consoles. No patient adverse event occurred as a result of the event. The console, motor, and flow probe were all replaced by the account. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2019-01970 |
| MDR Report Key | 8531375 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-19 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2018-04-24 |
| Date Added to Maude | 2019-04-19 |
| 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 | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-8005 |
| Manufacturer Phone | 78185 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE |
| Generic Name | PRIMARY CONSOLE |
| Product Code | DWA |
| Date Received | 2019-04-19 |
| Model Number | 201-30300 |
| Catalog Number | 201-30300 |
| Lot Number | 6407102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-19 |