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 2020-02-06 for PRIM CONS 1ST GEN, STANDALONE 201-30100 manufactured by Thoratec Switzerland Gmbh.
[178097525]
The motor associated with this event is being reported under mfr # 2916596-2020-00219. 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
[178097526]
It was reported that the patient was implanted with centrimag and a sudden "flow below minimum" alarm occurred without any manipulation of the patient or system. At the same time was noted on the rpm display. The clinical team noted that there was no blood flow through the pump and the pump had stopped. The primary console, motor, and flow probe were immediately changed and blood flow was restored. The patient had adequate oxygenation and was hemodynamically stable during the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00705 |
| MDR Report Key | 9678356 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-06 |
| 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 | PRIM CONS 1ST GEN, STANDALONE |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-01-24 |
| Model Number | 201-30100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-06 |