BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 22786242 · Received August 12, 2025

    Report

    Report Number
    2916596-2025-05346
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 1, 2025
    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; HOWEVER, NO ALARMS WERE REPRODUCED DURING TESTING. THE REPORTED CONTAMINATION FROM ADDITIONAL INFORMATION WAS CONFIRMED THROUGH VISUAL ANALYSIS AND IDENTIFIED AS FLUID INGRESS. LOG FILES WERE SUBMITTED AND DOWNLOADED FOR REVIEW AND DATA FROM THE EVENT DATES OF 05AUG2025 - 06AUG2025 WERE REVIEWED. THE LOG FILES CAPTURED DRIVELINE POWER FAULT ALARMS ON (B)(6) 2025 FROM 15:16:41 TO 19:00:37 THAT WERE ASSOCIATED WITH A PWR_B_BROKEN FAULTS. THE ALARM RESOLVED VIA CLEARING IT WHILE CONNECTED TO A POWER MODULE. AN ADDITIONAL DRIVELINE POWER FAULT ALARM WAS OBSERVED ON (B)(6) 2025 AT 11:54:01 AND DID NOT RESOLE BY THE TIME THE DRIVELINE WAS DISCONNECTED AT 12:08:40 TO EXCHANGE THE SYSTEM CONTROLLER AND MODULAR CABLE. NO OTHER NOTABLE ALARMS WERE OBSERVED IN THE LOG FILES. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 9173978) WAS RETURNED FOR ANALYSIS AND FLUID INGRESS WAS OBSERVED WITHIN THE INLINE CONNECTOR. DESPITE THE OBSERVED FLUID INGRESS, THE MODULAR CABLE WAS FUNCTIONALLY TESTED AND PASSED MOCK CIRCULATORY TESTING WITHOUT ANY ISSUE OR ALARMS ACTIVATING. THE MODULAR CABLE WAS STRIPPED, AND MINOR KINKING WAS OBSERVED ON ONE OF THE POWER WIRES. ADDITIONAL INFORMATION STATES THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AS A RESULT OF THE EVENT, MULTIPLE LOG FILES WERE RETRIEVED AS PART OF TROUBLESHOOTING, AND NO ALARMS WERE NOTED AFTER THE EXCHANGE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 9173978) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) 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 AUDIBLE), INCLUDING DRIVELINE POWER FAULT ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE CONTROLLER AND THE POWER CABLES. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 "ALARMS AND TROUBLESHOOTING" PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". HEARTMATE 3 LVAS PATIENT HANDBOOK SECTION 4 "LIVING WITH THE HEARTMATE 3" (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." AND "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT.¿ IN ADDITION, SECTION 5 "ALARMS AND TROUBLESHOOTING" CONTAINS A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", WHICH EXPLICITLY CAUTIONS THE USER NOT TO TWIST. 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE POWER FAULT ALARM. THE PATIENT WAS ADMITTED TO THE IMPLANTING CENTER. LOG FILES WERE DOWNLOADED; THE ALARM WAS CLEARED AND DID NOT REOCCUR. BASED ON LOG FILE ANALYSIS IT WAS NOTED THAT THE SYSTEM CONTROLLER WOULD LIKELY BE REPLACED AS PART OF THE TROUBLESHOOTING. THE PROBABLE CAUSE OF THE ALARM WAS CONTAMINATION OF THE CONNECTOR'S PINS BETWEEN THE PUMP CABLE AND MODULAR CABLE. THE CAUSE OF THE CONTAMINATION WAS UNKNOWN. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AND ANOTHER SET OF LOG FILES WERE DOWNLOADED, WHICH CONFIRMED THAT THE ALARM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419309 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 9173978 00813024011729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown