MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-29 for CENTRIMAG VAD KIT (OUS)- VAS/ECMO 201-90001 manufactured by Thoratec Corporation.
[152518913]
Approximate age of device: the event occurred on the date of implant. No further information was provided. The patient remains ongoing on the device. A supplemental report will be submitted when the manufacturer's investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[152518914]
The surgical team reportedly opened an expired centrimag implant kit and used the blood pump, cannulas, and tubing that were not expired according to each product's individual expiration date. Cannula connectors that had individual expiration dates that had already passed were discarded and replaced. The manufacturer's representative advised the surgical team to discard the entire kit. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2019-03674 |
| MDR Report Key | 8837194 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-29 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2019-07-05 |
| Date Added to Maude | 2019-07-29 |
| 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 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 VAD KIT (OUS)- VAS/ECMO |
| Generic Name | CENTRIMAG BLOOD PUMP KIT |
| Product Code | OJE |
| Date Received | 2019-07-29 |
| Model Number | 201-90001 |
| Catalog Number | 201-90001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-07-29 |