BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 24584990 · Received March 12, 2026

    Report

    Report Number
    2916596-2026-01472
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 18, 2026
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS ON THE MODULAR CABLE (LOT NUMBER 8132553) WAS CONFIRMED VIA LOG FILE ANALYSIS. THE LOG FILE CAPTURED INTERMITTENT POWER B BROKEN CONTROLLER FAULT FLAGS BEGINNING FROM 28FEB2026 AT 09:27:43. THESE FAULTS PROGRESSED TO ACTIVATE DRIVELINE POWER FAULT ALARMS AT 11:18:37. THESE ALARMS REMAINED ACTIVE FOR THE REMAINDER OF THE DATA CAPTURE. NO OTHER NOTABLE EVENTS WERE RECORDED. THE PUMP OPERATED AS INTENDED WITHIN THE EXPECTED SPEED RANGE THROUGHOUT THE DATA CAPTURE. AVAILABLE INFORMATION PROVIDED THAT THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED TO RESOLVE THE ALARMS. THE INLINE AND CONTROLLER CONNECTORS OF THE MODULAR CABLE WERE FOUND TO BE IN UNREMARKABLE PHYSICAL CONDITION. NO PRODUCTS WERE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE (LOT NUMBER 8132553) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. A ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDITORY), INCLUDING DRIVELINE POWER FAULT ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ¿ ¿LIVING WITH THE HEARTMATE 3¿ EXPLAINS HOW TO PROPERLY CARE FOR THE DRIVELINE AND INSTRUCTS THE USER ON HOW TO KEEP THE DRIVELINE CLEAN BY USING A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿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. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿ ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY DEPARTMENT FOR A DRIVELINE POWER FAULT ADVISORY ALARM. LOG FILE REVIEW WAS REQUESTED WHICH REVEALED POWER B DRIVELINE FAULTS STARTING ON (B)(6) 2026 AT 11:18 WHICH CONTINUED FOR THE REMAINDER OF THE LOG FILE. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. THE MODULAR CABLE PINS WERE NOTED TO APPEAR CLEAN BASED ON THE IMAGES PROVIDED. EXCHANGING THE SYSTEM CONTROLLER AND MODULAR CABLE RESOLVED THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646747 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8132553 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male