BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20531546 · Received October 25, 2024

    Report

    Report Number
    2916596-2024-07125
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    July 28, 2024
    Report Date
    October 25, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED MODULAR CABLE CONFIRMED WIRE DAMAGE CONSISTENT WITH FATIGUE THAT WOULD HAVE CAUSED THE COMMUNICATION FAULT ALARM CAPTURED IN THE SUBMITTED LOG FILES. THE HEARTMATE 3 MODULAR CABLE, LOT #161197, WAS RETURNED IN USED CONDITION. THE CONTROLLER AND INLINE CONNECTOR PINS APPEARED UNREMARKABLE. THE MODULAR CABLE FAILED WIRE CONTINUITY TESTING, AND THE WIRES OF THE MODULAR CABLE WERE FOUND TO HAVE SEVERAL INSTANCES OF WIRE CONDUCTOR DAMAGE, AS WELL AS WIRE KINKING AND INSULATION DAMAGE. THE WIRE CONDUCTOR DAMAGE OF THE YELLOW WIRE WOULD HAVE CAUSED THE DRIVELINE COMMUNICATION FAULT ALARM. AS THERE WERE NO OTHER NOTABLE ALARMS OR FAULTS IN THE SUBMITTED LOG FILES, THERE APPEARED TO HAVE BEEN ENOUGH CONTINUITY BETWEEN THE OTHER WIRES TO MAINTAIN NORMAL FUNCTION DURING SUPPORT. THE WIRE DAMAGE WAS CONSISTENT WITH FATIGUE DUE TO REPETITIVE FLEXING OVER TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT #161197, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 2 ¿SYSTEM OPERATIONS¿ EXPLAINS HOW TO REPLACE THE MODULAR CABLE. 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 ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND TO COUNSEL PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 7 ALSO DESCRIBES ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ STATES: "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." SECTION 3 ¿POWERING THE SYSTEM¿ AND SECTION 6 WARN THAT THE PATIENT MUST ALWAYS CONNECT TO THE POWER MODULE OR MPU FOR SLEEPING OR WHEN THERE IS A CHANCE OF SLEEP. A SLEEPING PATIENT MAY NOT HEAR SYSTEM ALARMS. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS CURRENTLY AVAILABLE. SECTION 4 ¿LIVING WITH THE HEARTMATE III¿ CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. SECTION 4 ALSO INSTRUCTS THE USER TO ¿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. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID.¿ SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. SECTION 5 ALSO OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 PRESENTED TO THE EMERGENCY ROOM (ER) WITH A COMMUNICATIONS FAULT ALARM. THE MODULAR CABLE WAS REPLACED. FOLLOWING THE MODULAR CABLE REPLACEMENT THE ALARMS HAD NOT REOCCURRED. LOG FILES WERE REVIEWED AND CONFIRMED DRIVELINE COMMUNICATION B FAULT ALARMS ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812021 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106525US 161197 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male