MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-10 for CENTRIMAG 1ST GENERATION PRIMARY CONSOLE 102954 manufactured by Thoratec Switzerland Gmbh.
[176011415]
The centrimag motor was captured under mfr# 2916596-2019-03827. The centrimag blood pump was captured under mfr# 2916596-2019-03835. 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
[176011416]
The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019. It was reported that the patient was in cardiogenic shock and was initiated on dual centrimag acute support with an oxygenator attached to the right-sided support. Going into the intensive care unit (icu), the left ventricular assist device (lvad) was set at 4000 with 4. 7lpm flow and the right vad was set at 2700 with 4lpm flow. Approximately an hour after getting into the icu from the operating room, the cardiologist received an s3 alarm with a loud noise coming from the motor and pump on the lvad and that the motor was hot to the touch. Healthcare professionals immediately switched to the backup motor and there have been no alarms since. The patient was in critical health status due to being in shock and not due to the event. It was also reported that there was additional incident on (b)(6) 2019 in the evening following the switch to full backup system due to rattling sound from pump and s3 alarm. No further alarms have occurred since the switch to full backup system. Photos were provided of the pump secured in the motor on the new system to ensure secure pump placement. On (b)(6) 2019, the patient experienced significant flow fluctuations and apparent suck down at drainage cannula. Volume was given to the patient but flow fluctuations persisted. The patient was taken to the catheterization lab where a "huge left ventricle thrombus" was identified. This was thought to be the cause of the drop in flow and flow fluctuations and the patient was otherwise doing fine. Treatment for the thrombus was to explant the centrimag and implant with a heartmate 3 lvad on (b)(6) 2019. The centrimag console was added as a result of the investigation that concluded other causes may have contributed to the reported events besides thrombus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00153 |
| MDR Report Key | 9576361 |
| Report Source | OTHER |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-01-10 |
| 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 | CENTRIMAG 1ST GENERATION PRIMARY CONSOLE |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-01-10 |
| Model Number | 102954 |
| Catalog Number | 102954 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-10 |