MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-13 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) 201-90401 manufactured by Thoratec Switzerland Gmbh.
[181786933]
This report addresses the console. The motor is reported under mfr. #2916596-2020-00790. 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
[181786954]
It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) support while in surgery. The console alarmed that the pump was stopped, which was followed by low flow and low pressure alarms. The perfusionist noticed that the speed was zero rotations per minute (rpm), that flow had stopped and that retrograde flow was evident. The ecmo delivery line was clamped to prevent further retrograde flow and the perfusionist pressed the speed increase button to 2000 rpm, which restarted and sped up the pump. The clamp was removed and the speed was further increased. The perfusionist attempted to access the console log but the log would not display on the screen. The log screen flashed momentarily before switching back to the main screen; this happened 3 or 4 times. The console was exchanged. The motor and flow probe were not exchanged and there were no further problems. The log screen on the backup console displayed as expected. The patient was transferred to the icu and ecmo was continued for several more days without issue. The patient was hemodynamically compromised for approximately 1 minute at the time of the failure and a further 30 seconds as the console was exchanged. The low flow and low pressure alarms resolved after the speed was increased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00792 |
| MDR Report Key | 9708521 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-11-07 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Model Number | 201-90401 |
| Catalog Number | 201-90401 |
| Lot Number | 6224746 |
| 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 | 2020-02-13 |