MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-13 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-90411 manufactured by Thoratec Switzerland Gmbh.
[175023512]
This event was also reported against the centrimag motor under mfr. Report #2916596-2020-00002. Patient info was requested but not provided. 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
[175023513]
It was reported that the patient was on bi-vad centrimag (cmag) support with complaint of no flow showing on the right ventricular assist device (rvad) side. Patient was asymptomatic and flow appeared normal as patient was stable. Attempted new flow probe on the right side to no avail. Used the flow probe from the left side to ensure the flow probe worked and it did. That same flow probe was then attached to the rvad console and did not record a flow. The team then decided to switch out the rvad console with the backup console and flow again was recording. When the original rvad was attached to the mock loop, flow was normal. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2019-06108 |
| MDR Report Key | 9582048 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-01-13 |
| Model Number | 201-90411 |
| Catalog Number | 201-90411 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2020-01-13 |