THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
Report
- Report Number
- 2916596-2025-06568
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- October 1, 2025
- Report Date
- December 18, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P060040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BATTERY MODULE ALARM ON THE SYSTEM CONTROLLER WAS CONFIRMED VIA THE SUBMITTED LOG FILE. A REVIEW OF THE SUBMITTED LOG FILE (B)(4) SPANNED APPROXIMATELY 5 DAYS (TIMESTAMPS 1330:22:30 TO 1335:11:37 IN A DAYS: HOURS:MINUTES FORMAT). THE LOG FILE REVEALED THAT AT 1335:11:26, A CONTROLLER CELL LOW ALARM BECAME ACTIVE. THE LOG FILE ADDITIONALLY CAPTURED THAT THE DRIVELINE WAS DISCONNECTED AND RECONNECTED A FEW TIMES BETWEEN THE TIMESTAMPS OF 1335:11:37 AND 1335:11:43. THE CONTROLLER ALSO ENTERED BACKUP MODE DURING THIS TIMEFRAME. THE DRIVELINE REMAINED DISCONNECTED AFTER 1335:11:43, WHICH IS CONSISTENT WITH THE CONTROLLER'S EXCHANGE. THE HEARTMATE II SYSTEM CONTROLLER, SERIAL (B)(4), WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION STATED THAT THE CONTROLLER WAS EXCHANGED WHICH RESOLVED THE ISSUE. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. ALL SYSTEM CONTROLLER MAINTENANCE AND THE PROPER ACTIONS TO MAINTAIN THE INTEGRITY OF THE CONTROLLER ARE DESCRIBED IN PATIENT HANDBOOK. ALL SYSTEM CONTROLLER WARNING LIGHTS AND SOUNDS AND THE PROPER ACTIONS ASSOCIATED WITH THEM ARE DESCRIBED IN PATIENT HANDBOOK. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
IT WAS ADDITIONALLY REPORTED THAT A PUMP SHUTDOWN WITHOUT THE TYPICAL INCREASE IN PUMP POWER WAS ALSO RECORDED, MAKING DRIVELINE DAMAGE A LOW SUSPICION BUT NOT COMPLETELY RULED OUT.
IT WAS REPORTED THAT ON (B)(6) 2025 AT APPROXIMATELY 4:30 AM A SYSTEM CONTROLLER "BATTERY MODULE" ALARM OCCURRED, AND THE NURSE REPLACED THE CONTROLLER. AFTER THE CONTROLLER EXCHANGE A TEMPORARY RED HEART ALARM OCCURRED AROUND 11:50 AM ON THE SAME DAY. UPON CHECKING THE SYSTEM MONITOR HISTORY A 'REPLACE SYSTEM CONTROLLER' MESSAGE WAS RECORDED, AND THE CONTROLLER WAS REPLACED AGAIN. LOG FILES FROM BOTH CONTROLLER WERE SUBMITTED FOR REVIEW. LOG FILES FROM THE FIRST CONTROLLER EXCHANGED CAPTURED CONTROLLER CELL BATTERY LOW EVENTS PRIOR TO CHANGING THE CONTROLLER. THE LOG FILES FROM THE SECOND CONTROLLER CAPTURED THE CONTROLLER CONNECTED TO POWER BRIEFLY AND THEN IT LOOKED LIKE THE CONTROLLER LOST POWER AS THE TIMESTAMP RESET BACK TO ZEROS. THE POWER WAS RESTORED TO THE CONTROLLER, AND THE PUMP WAS OPERATING ABOUT 7 HOURS AND THEN A PUMP STOP OCCURRED WHILE USING WALL POWER AND ANOTHER PUMP STOP OCCURRED AROUND 40 MINUTES LATER, STILL ON WALL POWER. IT APPEARED THAT THE CONTROLLER WAS CHANGED ABOUT AN HOUR AFTER THE PUMP STOP. NO 'REPLACE SYSTEM CONTROLLER' EVENTS WERE NOTED IN THE LOG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2029656 | THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 103696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |