MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-09 for CENTRIMAG MOTOR, US 102956 manufactured by Thoratec Switzerland Gmbh.
[117022235]
The initial submission of this event was reported by the manufacturer under mfr. Report # 3003306248-2011-00003. 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
[117022236]
The patient was placed on centrimag system support on (b)(6) 2011. It was reported that during bilateral centrimag support of a patient, the centrimag primary console supporting the right heart had stopped when the ac power was removed. The console was plugged back into ac power but the pump did not restart and a burning smell started to emit from the console. The patient was then switched over to a second primary console and second centrimag motor which also failed to restart the pump. The perfusionist also reported the option to set the pump rpm was not available with the second primary console even after powering the unit on/off multiple times. The patient was then switched back to the original centrimag motor but stayed with the second primary console which did restart the pump. The perfusionist also reported an unusual "motor disconnected" message during the first few minutes after the pump was restarted. The patient was without right heart support for approximately 20 minutes. No ill effects were reported while the patient was not on support. The patient expired on (b)(6) 2011 for cause unrelated to the centrimag equipment. It was not known on what date or whether the patient was weaned off the centrimag equipment prior to the patient expiring, and therefore, it cannot be determined how long the patient was supported by the centrimag system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2018-03419 |
| MDR Report Key | 7770797 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-09 |
| Date of Event | 2011-03-21 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-09 |
| 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, US |
| Generic Name | CENTRIMAG MOTOR |
| Product Code | DSW |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2011-03-22 |
| Catalog Number | 102956 |
| 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 | 2018-08-09 |