BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 22509932 · Received July 15, 2025

    Report

    Report Number
    2916596-2025-04344
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 15, 2025
    Report Date
    October 29, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE FAULT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILE; HOWEVER, IT WAS NOT REPRODUCED. A REVIEW OF THE SUBMITTED LOG FILES SPANNED APPROXIMATELY 10 DAYS ((B)(6) 2025 ¿ (B)(6) 2025 PER TIME STAMP). THROUGHOUT THE ENTIRE LOG FILE WHILE CONNECTED TO BATTERIES AND THE MOBILE POWER UNIT (MPU), THE DRIVELINE FAULT ALARM INTERMITTENTLY ACTIVATED DUE TO A HIGHER PHASE 2 COMPARED TO PHASES 1 AND 3. THE YELLOW WRENCH ALARM WAS ACTIVE DURING THIS ALARM AS WELL. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. A REVIEW OF THE SUBMITTED BACKUP CONTROLLER LOG FILE (013709) SPANNED APPROXIMATELY 3 DAYS ((B)(6) 2024, (B)(6) 2000, AND (B)(6) 2025 PER TIME STAMP). PHASE 2 MEASURED HIGHER COMPARED TO PHASES 1 AND 3, BUT NOT ENOUGH TO TRIGGER AN ALARM. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED SYSTEM CONTROLLER, SERIAL PCX-17473, WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. THE CONTROLLER WAS ABLE TO SUPPORT PUMP FUNCTION FOR AN EXTENDED PERIOD OF TIME. NO ALARMS WERE PRODUCED WHILE TESTING. IMPEDANCE ON PHASES 1, 2, AND 3 WERE MEASURED AFTER TESTING AND WERE ALL WITHIN SPECIFICATIONS. THE PROVIDED INFORMATION STATED THAT THE DRIVELINE HAD MULTIPLE TEARS, HOWEVER THE SHEATH LOOKED INTACT. THERE WERE MULTIPLE AREAS WITH RESCUE TAPE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED DRIVELINE FAULT ALARM CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. INCIDENTAL FINDINGS: CUT IN THE BLACK POWER CABLE JACKET, FLUID INGRESS IN THE WHITE POWER CABLE STRAIN RELIEF, HOUSING, AND LCD, WIRE FATIGUE. 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. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE II INSTRUCTIONS FOR USE SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS, INCLUDING DRIVELINE FAULT ALARMS. HEARTMATE II INSTRUCTIONS FOR USE SECTION 8- ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK REV. C SECTION 6- ¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. THE IFU STATES HOW TO STORE, TRANSPORT, AND MAINTAIN THE SYSTEM CONTROLLER TO PREVENT DAMAGE SUCH AS TEARS AND FLUID INGRESS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A ROUTINE FOLLOW UP VISIT AND DRIVELINE FAULT ALARMS WERE SEEN ON THE HEARTMATE TOUCH. HOWEVER, NO DRIVELINE FAULT ALARMS WERE FOUND ON THE SYSTEM CONTROLLER. THE DRIVELINE WAS NOTED TO HAVE MULTIPLE TEARS WITH MULTIPLE AREAS OF RESCUE TAPE, BUT THE SHEATH LOOKED INTACT. THE LOG FILE CAPTURED SEVERAL DRIVELINE FAULT ALARMS THROUGHOUT THE EVENT HISTORY. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARM APPEARED TO HAVE CLEARED FOLLOWING THE CONTROLLER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146158 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 6866160 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male