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 2020-03-04 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) 201-90401 manufactured by Thoratec Switzerland Gmbh.
[184058583]
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
[184058584]
It was reported that a newborn patient was implanted on (b)(6) 2020 at (b)(6) center with venous-arterial extracorporeal membrane oxygenation (ecmo) and transferred to (b)(6) hospital. Supporting therapy including thrombo-concentrates and fibrinogen administered. The centrimag (cmag) system was stable on 2900 rpm with flow 290 - 300 mls/min. On (b)(6) 2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line. There was no improvement so the cmag circuit was transferred to a backup centrimag console and motor, but there was no noted improvement. The new cmag circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return). Support therapy was continued, including thrombo-concentrates and fibrinogen administration. On (b)(6) 2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line. There was no improvement, so a new maquet pls ecmo circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return). The patient continued to receive therapy without any event and elective decommissioning of ecmo on (b)(6) 2020. Both the initial cmag system and backup cmag system had to be exchanged due to low flow. This event is also reported under mfr #2916596-2020-01175, mfr# 2916596-2020-01174, mfr#2916596-2020-01177.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01176 |
| MDR Report Key | 9785196 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-04 |
| 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 WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-03-04 |
| Model Number | 201-90401 |
| Lot Number | 6525865 |
| 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 | 2020-03-04 |