BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22881564 · Received August 24, 2025

    Report

    Report Number
    2916596-2025-05610
    Event Type
    Malfunction
    Date Received
    August 24, 2025
    Date of Event
    July 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILES. THE SUBMITTED LOG FILES REVEALED A DRIVELINE POWER FAULT ALARM, ASSOCIATED WITH POWER A LINE FAULTS (PWR_A_BROKEN), WAS ACTIVE THROUGHOUT THE DURATION OF THE LOG FILE. A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE MODULAR CABLE (LOT: 9213776) WAS NOT RETURNED FOR TESTING. HOWEVER, PHOTOS OF THE MODULAR CABLE WERE SUBMITTED. THE PHOTOS WERE CONSISTENT WITH THE REPORTED MODULAR CABLE EXCHANGE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE POWER FAULT ALARM APPROXIMATELY SIX HOURS AFTER A SYSTEM CONTROLLER EXCHANGE. THE ACCOUNT WAS UNABLE TO DETERMINE THE CAUSE OF THE ALARM. IT WAS FURTHER COMMUNICATED THAT THE DRIVELINE POWER FAULT ALARM AFTER A ¿COMPLETE ALARM CLEARANCE SEQUENCE¿ WAS PERFORMED. NO FURTHER ALARMS OCCURRED, AND THE SYSTEM RESUMED NORMAL OPERATION. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE TIME. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM APPROXIMATELY ONE MONTH LATER WITH CONSISTENT DRIVELINE POWER FAULT ALARMS. THE PATIENT STATED THAT THEY HAD BEEN EXPERIENCING THE ALARMS DAILY SINCE THEIR PREVIOUS EMERGENCY ROOM VISIT. A SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGE WERE COMPLETED, AND THE DRIVELINE POWER FAULT ALARMS RESOLVED. A ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO STATES, ¿CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINE ALL SYSTEM CONTROLLER ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THESE SECTIONS ALSO PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN SUB-SECTIONS ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 8 OF THE IFU, ¿EQUIPMENT STORAGE AND CARE¿, AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH AND IF MORE AGGRESSIVE CLEANING IS NEEDED, TO USE WARM WATER AND MILD DISH SOAP. SECTION 8 OF THE PATIENT HANDBOOK ENTITLED ¿HANDLING EMERGENCIES¿ LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER FAULT ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PRESENTED TO CLINIC ON (B)(6) 2025 WITH CONSISTENT DRIVELINE POWER FAULT ALARMS AND REPORTED TO HAVE BEEN EXPERIENCING THEM DAILY SINCE THE EMERGENCY ROOM VISIT. LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILE CONFIRMED THE DRIVELINE POWER A FAULT ALARMS ON (B)(6) 2025. THE PATIENT'S MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. ADDITIONAL LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILES APPEARED NORMAL, AND THE DRIVELINE POWER FAULTS DID NOT RETURN. SUBMITTED PHOTOS OF THE INLINE CONNECTOR PINS APPEARED NORMAL AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486485 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9213776 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male