THORATEC TLC-2
Report
- Report Number
- MW1026803
- Event Type
- Injury
- Date Received
- November 19, 2002
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
THE COMPRESSOR SEIZED DUE TO A FAILURE OF ONE OF THE JOURNAL BEARINGS.
ADD'L INFO REC'D FROM MFR 1/21/03: THE TLC-II PORTABLE VAD DRIVER WAS RECEIVED AT THORATEC AND POWERED ON. THERE WAS NO AIR PRESSURE BEING DELIVERED TO THE VADS. THE COMPRESSOR COULD NOT BE HEARD RUNNING. WHEN THE DRIVER WAS OPENED IT WAS FOUND THAT THE COMPRESSOR WAS SEIZED (CRANKSHAFT WOULD NOT ROTATE). THE COMPRESSOR CRANKCASE WAS OPENED AND INSPECTED. ONE OF THE CONNECTING ROD JOURNAL BEARINGS HAD FAILED. THE FAILED CONNECTING ROD WAS REMOVED AND RETURNED TO THE BEARING MFR FOR INVESTIGATION. A DETAILED FAILURE ANALYSIS WAS PERFORMED ON THE BEARING AND CONNECTING ROD WHICH INCLUDED GREASE INSPECTION, VISUAL INSPECTION, HAND ROTATION AND MEASUREMENTS OF ARMATURE HOLE DIMENSIONS AND ROUNDNESS. THE ROOT CAUSE OF FAILURE WAS DETERMINED TO BE AN UNDERSIZED AND OUT OF ROUND MOUNTING HOLE WHICH LEAD TO AN EXCESSIVE AND UNEVEN PRESS FIT. THIS CAUSED THE BEARING TO FAIL. AFTER THE OCCURRENCE OF A SIMILAR FAILURE IN DECEMBER 2001, THE VENDOR INITIATED A PREVENTIVE ACTION TO REDUCE THE PROBABILITY OF OCCURRENCE OF THIS TYPE OF FAILURE. THE VENDOR INSTITUTED TIGHTER QUALITY CONTROLS (INCREASED AQL) FOR THE BEARING DIAMETER, CONNECTING ROD HOLE DIAMETERS AND CONNECTING ROD HOLE ROUNDNESS. THE CONNECTING ROD INVOLVED IN THIS COMPLAINT WAS MANUFACTURED IN NOVEMBER 1999-PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THORATEC TLC-2 | DRIVER FOR BIVAD | DSQ | THORATEC CORP. | TLC-2 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |