MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-11 for CENTRIMAG MOTOR, OUS 201-10002 manufactured by Thoratec Switzerland Gmbh.
[116890439]
Patient information not provided. The device returned for analysis. The complaint investigation determined the reported difficulty was the result of a design related wear issue. After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag. Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
Patient Sequence No: 1, Text Type: N, H10
[116890440]
It was reported that the system has been running on a patient for 10 days (as part of bivad support). After returning the centrimag console to main power, the console gave a 'motor fail' alarm and the motor stopped. The 2nd console (lvad) was not affected. The outflow line was clamped and the patient was switched over to another primary console and motor and resumed support. The patient was asymptomatic. The onset of this event did not require the patient to undergo additional intervention. No additional information was provided. This event was previously not reported due to the backup system available. Abbott made the decision on july 13, 2018 to initiate a voluntary recall; therefore this event is being upgraded to reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2018-03422 |
| MDR Report Key | 7775236 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-11 |
| Date of Report | 2018-08-11 |
| Date of Event | 2005-05-18 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-11 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG MOTOR, OUS |
| Generic Name | MOTOR |
| Product Code | DSW |
| Date Received | 2018-08-11 |
| Returned To Mfg | 2005-05-20 |
| Model Number | 201-10002 |
| Catalog Number | 201-10002 |
| 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 | 2018-08-11 |