MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for CENTRIMAG MOTOR, US 102956 manufactured by Thoratec Switzerland Gmbh.
[186754948]
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
[186754949]
Related manufacturer report number: 2916596-2019-06006. It was reported that the patient had a challenging course requiring crrt and multiple intubations. There was no readmission because the patient was never discharged post-implant transferred from university of utah to slc vamc on (b)(6) 2019. On (b)(6) 2019, they had an acute intracranial hemorrhage with bleeding into the ventricles due to a cardioembolic stroke with conversion to hemorrhagic stroke. The cva was confirmed with ct. It happened fairly suddenly and was extremely severe, described by clinician as? Devastating and survivable head bleed?. After discussion with the patients family, care was withdrawn on (b)(6) 2019, and patient passed away on (b)(6) 2019. The death was not device related. The device operated as expected. No further or additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01788 |
| MDR Report Key | 9902608 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-31 |
| 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 MOTOR, US |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | KFM |
| Date Received | 2020-03-31 |
| Model Number | 102956 |
| Catalog Number | 102956 |
| 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 | 2020-03-31 |