MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-90411 manufactured by Thoratec Switzerland Gmbh.
[179423899]
This event was also reported against the centrimag motor in mfr. Report #2916596-2020-00490. 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
[179423900]
It was reported that the patient was on venous-venous extracorporeal membrane oxygenation (ecmo) while awaiting a lung transplant. The patient had been on centrimag for about 5 days prior to the event occurring. On the evening of (b)(6) 2019, the patient was being prepared to go to the operating room for the lung transplant when the flow on the centrimag console showed '- - - -'. No alerts or alarms were displayed. A new console and flow probe was added to see if a flow would be displayed, but kept the original motor in place connected to the original console. The addition of the second console and flow probe was just to read flow. The flow remained steady and the backup console and flow probe read the flow while the original console still read the rpms. During this troubleshooting the original console displayed dashes while the new console and flow probe displayed a flow. During the lung transplant, the motor was switched over to the backup console and removed the original console and flow probe. So now the patient had the backup console, flow probe and the same original motor. After the case, the original console and flow probe was used on the patient? S line and it read flow again, so it seemed like it was working fine. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00492 |
| MDR Report Key | 9648057 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-12-29 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 201-90411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2020-01-30 |