BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22370482 · Received July 1, 2025

    Report

    Report Number
    2916596-2025-04100
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 29, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 DRIVELINE POWER FAULT ALARM WHILE CONNECTED TO THE MODULAR CABLE, LOT NUMBER 7882630, WAS CONFIRMED VIA LOG FILE ANALYSIS. LOG FILES WERE SUBMITTED AND DOWNLOADED FOR REVIEW AND DATA FROM THE EVENT DATES OF 11JUN2025 TO 13JUN2025 WERE REVIEWED. THE LOG FILES CAPTURED A DRIVELINE POWER FAULT ALARM ON (B)(6) 2025 STARTING AT 14:00:08 AND DID NOT RESOLVE BY THE TIME THE CONTROLLER WAS EXCHANGED AT 14:07:50. THE ONSET OF THE ALARM WAS ASSOCIATED WITH A PWR_B_BROKEN FAULTS. 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 WAS RETURNED FOR ANALYSIS AND WAS FUNCTIONALLY TESTED. THE MODULAR CABLE PASSED ALL TESTING WITHOUT ANY ISSUE OR ALARMS ACTIVATING. ADDITIONAL INFORMATION STATES (B)(6) WAS THE CONTROLLER THE PATIENT EXCHANGED THEMSELVES ONTO DURING THE ISSUE, THE CONTROLLER THAT HAD THE YELLOW WRENCH ON WAS (B)(6) WHICH WAS THEIR INITIAL PRIMARY CONTROLLER. A ROOT CAUSE FOR THE DAMAGE TO THE CABLE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEAL THAT THE HEARTMATE MODULAR CABLE, LOT NUMBER 7882630, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 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. THIS SECTION ALSO WARNS TO NEVER "SUBMERGE THE DRIVELINE, MODULAR CONNECTOR, SYSTEM CONTROLLER, OR ANY EXTERNAL SYSTEM COMPONENTS (SUCH AS THE POWER MODULE, THE MOBILE POWER UNIT, BATTERIES, POWER CABLES, OR BATTERY CLIPS) IN WATER OR LIQUID. SUBMERSION IN WATER OR LIQUID MAY CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP." 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 CABLE. 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. 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 HAD A YELLOW WRENCH ALARM AT HOME. THE PATIENT PANICKED AND PERFORMED THEIR OWN SYSTEM CONTROLLER EXCHANGE. THEY WENT TO THE CLINIC AND LOG FILES WERE DOWNLOADED. A DRIVELINE POWER FAULT ALARM WAS DISPLAYED. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE RECORDED A DRIVELINE POWER FAULT ON 13JUN2025 AT 14:00:08. MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. THE CONTROLLER AND MODULAR CABLE WERE EXCHANGED. NEW LOG FILES WERE SENT FOR REVIEW POST EXCHANGE. NO ALARMS OR EVENTS WERE NOTED ON LOG FILES UPON REVIEW. THE EVENT LOG CONTAINED ALARMS ASSOCIATED WITH THE EQUIPMENT EXCHANGE. FOLLOWING THE INITIAL ALARMS, THE PUMP APPEARED TO BE OPERATING AS INTENDED WITH NO ACTIVE FAULTS. A PICTURE OF THE DRIVELINE WAS UNABLE TO BE TAKEN AS THE PATIENT BECAME SYMPTOMATIC DURING THE CONTROLLER AND MODULAR CABLE EXCHANGE AND NEEDED TO BE RECONNECTED IMMEDIATELY. THE PATIENT FELT LIGHTHEADED BRIEFLY AND THEIR EYES STARTED TO CLOSE BUT THIS RESOLVED ONCE THE PUMP WAS RECONNECTED. THE MODULAR CABLE THAT WAS REPLACED WAS INSPECTED AND THERE WAS NO BUILD UP ON THE INSIDE OF THE CONNECTION NOTED. THE PATIENT WAS NOTED TO BE DOING WELL AFTER THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429912 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7882630 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other