BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 23180744 · Received September 30, 2025

    Report

    Report Number
    2916596-2025-06217
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 28, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA THE LOG FILE. THE REPORTED EVENT OF THE RESCUE TAPE BEING APPLIED TO COVER DAMAGE TO THE MODULAR CABLE WAS CONFIRMED DURING INSPECTION. THE SYSTEM CONTROLLER EVENT LOG FILES WERE REVIEWED, AND TIMESTAMPS SPANNED APPROXIMATELY 18 HOURS (01:36:45 TO 19:14:04 ON 17SEP2025). ON 17SEP2025, A DRIVELINE POWER FAULT ALARM WAS ACTIVE; HOWEVER, THE REASON FOR THIS ALARM¿S ONSET WAS NOT CAPTURED AS IT WAS OVERWRITTEN WITH NEWER DATA. THIS ALARM RESOLVED AS IT WAS CLEARED THROUGH THE SYSTEM MONITOR BY THE CUSTOMER. THE DRIVELINE WAS DISCONNECTED, AND THE SYSTEM CONTROLLER WAS SHUT DOWN ON 17SEP2025. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE WHILE THE DRIVELINE WAS CONNECTED. THE MODULAR CABLE, LOT NUMBER: 8894604, RETURNED COVERED IN RESCUE TAPE. UPON REMOVING THE RESCUE TAPE, THE POLYURETHANE OUTER JACKET WAS FOUND TO BE BRITTLE AND DETACHED IN SEVERAL AREAS. ADDITIONALLY, THE BEND RELIEFS WERE FOUND TO BE DISCOLORED. THE MODULAR CABLE WAS TESTED WITH THE RETURNED SYSTEM CONTROLLER ON A MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. THE INTEGRITY OF THE MODULAR CABLE'S WIRES WAS TESTED AND PASSED WITHOUT ISSUE. THE POLYURETHANE JACKET AND UNDERLYING PROTECTIVE LAYERS WERE REMOVED, AND THE INTERNAL WIRES WERE FOUND TO BE UNREMARKABLE. THE REPORTED DRIVELINE POWER FAULT ALARM COULD NOT BE REPRODUCED DURING TESTING. THE PROVIDED INFORMATION STATED THE PATIENT IS ASYMPTOMATIC, AND THE CUSTOMER WAS ABLE TO CLEAR THE DRIVELINE POWER FAULT ALARM, AND IT DID NOT RETURN. ADDITIONAL INFORMATION CONFIRMED THAT THE RESCUE TAPE WAS ONLY APPLIED TO THE MODULAR CABLE AND THAT THE PUMP CABLE WAS NOT DAMAGED. THE ROOT CAUSE OF THE DRIVELINE POWER FAULT ALARM COULD NOT BE CONCLUSIVELY DETERMINED DURING THIS INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE HEARTMATE 3 VAD MODULAR CABLE, LOT NUMBER: 8894604, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK REV. A ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 LVAS IFU REV. D SECTION 2 ENTITLED ¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK REV. A SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ STATE THAT DAMAGE TO THE ELECTRICAL WIRES INSIDE THE DRIVELINE IS NOT ALWAYS VISIBLE. THE USER SHOULD BE ALERT FOR SIGNS OF DAMAGE, INCLUDING FLUID LEAKING FROM THE EXTERNAL PORTION OF THE DRIVELINE. HEARTMATE 3 LVAS IFU REV. D SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ AND HEARTMATE 3 PATIENT HANDBOOK REV. A SECTION 4 ENTITLED ¿LIVING WITH THE HEARTMATE 3¿ INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE. HEARTMATE 3 LVAS IFU REV. D SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK REV. A SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS. ADDITIONALLY, INSTRUCTIONS REGARDING DRIVELINE CARE ARE FOUND IN SUB-SECTIONS ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". HEARTMATE 3 LVAS IFU REV. D SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK REV. A SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESS HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. THE HEARTMATE 3 PATIENT HANDBOOK REV. A 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRIVELINE POWER FAULT ALARM THAT BEGAN IN THE MORNING OF (B)(6) 2025 AROUND 01:36 AM. THEY ALSO HAD INTERMITTENT LOW FLOW ALARMS AND WERE ASYMPTOMATIC. DRIVELINE POWER FAULT ALARM WAS CLEARED AND IT HAD NOT RETURNED. IT WAS NOTED THAT THERE WAS RESCUE TAPE ON THE ENTIRE DRIVELINE. LOG FILE REVIEW CONFIRMED THE REPORTED DRIVELINE POWER FAULTS. THE LOG ALSO CONTAINED NO EXTERNAL POWER MODE DURING THESE EVENTS. MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. ADDITIONAL LOG FILES CONFIRMED THAT THE DRIVELINE POWER FAULT DID NOT RETURN POST EXCHANGE, AND THE PICTURE OF THE MODULAR CABLE CONNECTOR WAS NOT CONCERNING FOR CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105088 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8894604

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male