MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-10 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT L201-90411 201-90411 manufactured by Thoratec Switzerland Gmbh.
[179792282]
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
[179792283]
It was reported that the centrimag console alarmed battery module fail twice and the alarm hasn't repeated. The doctor was at the bedside when this happened and elected not to change the console. It was reported it was advised to keep a backup available and not transport the patient without being informed. The battery indicator shows 3. 45h and the console has been plugged in the entire time. The rpms were 3800 with 4. 5 l/min flow. No adverse event reported, and no additional information reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00525 |
| MDR Report Key | 9690001 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2020-02-10 |
| 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 |
| 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 CA 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 RENT |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-10 |
| Returned To Mfg | 2020-01-29 |
| Model Number | L201-90411 |
| Catalog Number | 201-90411 |
| Lot Number | IFS103676 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-10 |