BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 23881110 · Received December 23, 2025

    Report

    Report Number
    2916596-2025-07954
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 8, 2025
    Report Date
    February 24, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011729
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULTS WAS CONFIRMED VIA LOG FILE ANALYSIS. THE REPORTED EVENT OF CORROSION ON THE MODULAR CABLE WAS UNABLE TO BE CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 8922874) WAS NOT RETURNED FOR ANALYSIS. THE CONTROLLER EVENT LOG FILE DID NOT CONTAIN DATA FROM THE REPORTED EVENT DATES OF 08DEC2025 ¿ 19DEC2025. THE PERIODIC LOG FILE CONTAINED DATA CAPTURED ONCE PER DAY AND SHOWED AN ACTIVE DRIVELINE POWER FAULT ALARM FROM 08DEC2025 THROUGH 19DEC2025. THE ALARM HAD RESOLVED WHEN DATA WAS CAPTURED ON 20DEC2025, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE ALARM WAS MANUALLY CLEARED ON 19DEC2025. DUE TO THE NATURE OF PERIODIC LOG FILES, THE EXACT CAUSE OF THE DRIVELINE POWER FAULT ALARM COULD NOT BE DETERMINED. THE DRIVELINE POWER FAULT ALARM DID NOT APPEAR TO PREVENT THE PUMP FROM OPERATING AS INTENDED IN THE DATA REVIEWED. PROVIDED INFORMATION INDICATED THAT THE ALARM WAS MANUALLY CLEARED, AND DID NOT REACTIVATE. THE ROOT CAUSE OF THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS NOT ABLE TO BE DETERMINED VIA THIS INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. A, ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTIONS 2 AND 6 OF THE IFU AND SECTIONS 2 AND 4 OF THE PATIENT HANDBOOK CAUTION THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE AND FURTHER EMPHASIZE NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, WHICH MAY CAUSE DAMAGE TO THE WIRES. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK ALSO INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USED TO CALL THE HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK PROVIDE INSTRUCTIONS REGARDING HOW TO CARE FOR THE DRIVELINE IN SUB-SECTIONS ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 8 OF THE IFU AND SECTION 6 OF THE PATIENT HANDBOOK ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. SECTION 2 OF THE IFU - ¿SYSTEM OPERATIONS¿ AND SECTION 2 OF THE PATIENT HANDBOOK - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. 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 DEVICE HISTORY RECORDS WERE REVIEWED AND REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. 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 FURTHER REPORTED THAT ON (B)(6)2025, THE PATIENT REPORTED A POWER TRANSMISSION ALARM. ON 19DEC2025, AT 3:21 P.M. (TIME RECORDED IN THE SYSTEM CONTROLLER), THE PREVIOUSLY OCCURRING DRIVELINE POWER FAULT ALARM WAS CLEARED. UNFORTUNATELY, THE ALARM RETURNED. ULTIMATELY, THE SYSTEM CONTROLLER, AND MODULAR CABLE WERE EXCHANGED. IT WAS SUSPECTED THAT THE PATIENT MIGHT HAVE CORROSION IN THE DRIVELINE CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A DRIVELINE POWER FAULT ALARM. THE HOSPITAL SUSPECTED IT COULD BE MODULAR CABLE CORROSION. THE ALARM HAD NOT BEEN RESOLVED. IT WAS INFORMED THAT THE PROCEDURE FOR VERIFYING THE FAULT AND POSSIBLE ACTIONS WERE BEING DETERMINED. THE PATIENT WAS OUTSIDE THE IMPLANTING CENTER, AND IT WAS UNABLE TO DOWNLOAD LOG FILES TO START REMOTE TROUBLESHOOTING. THE MODULAR CABLE REMAINED IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058484 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 10356347 00813024011729

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male