BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 16427246 · Received February 23, 2023

    Report

    Report Number
    2916596-2023-01188
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 30, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT WAS CONFIRMED VIA LOG FILE ANALYSIS. THE MODULAR CABLE (LOT NUMBER: 7880086) WAS RETURNED FOR ANALYSIS AND A LOG WAS SUBMITTED FOR REVIEW AND SHOWED EVENTS SPANNING APPROXIMATELY 6 DAYS ((B)(6) 2023 ¿ (B)(6) 2023 PER TIMESTAMP). DRIVELINE POWER FAULT ALARMS THAT WERE CORRELATED WITH FUSE A BEING OPEN WERE ACTIVE FROM (B)(6) 2023 AT 16:59:32 UNTIL THE END OF THE LOG FILE ON (B)(6) 2023 AT 13:54:05. PUMP OPERATION WAS NOT AFFECTED BY THESE ALARMS. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED MODULAR CABLE WAS CONNECTED TO A TEST SYSTEM CONTROLLER, TEST POWER MODULE, AND A MOCK LOOP. A DRIVELINE POWER FAULT ALARM BECAME ACTIVATED UPON MANIPULATION OF THE MODULAR CABLE AT THE SITE OF DAMAGE TO THE OUTER JACKET. THE MODULAR CABLE WAS THEN TESTED PER QAP, MODULAR CABLE TEST TO EVALUATE THE INTEGRITY OF ITS WIRES AND PASSED TESTING. ADDITIONAL RESISTANCE TESTING WAS PERFORMED ON THE CABLE AND UPON FLEXING THE CABLE AT THE SITE OF DAMAGE, THE BROWN WIRE (POWER A) WAS ELECTRICALLY OPEN. THE OUTER JACKET WAS STRIPPED, AND A BREAK IN THE BROWN WIRE WAS OBSERVED. WIRE FATIGUE WITHIN THE BROWN WIRE WOULD CAUSE A DRIVELINE POWER FAULT. THE CAUSE FOR THE DRIVELINE POWER FAULTS WAS DUE TO DAMAGE TO THE DRIVELINE¿S UNDERLYING BROWN WIRE (POWER A). WHILE NOT CONCLUSIVELY DETERMINED, THE WIRE FATIGUE APPEARS TO BE RELATED TO THE REPETITIVE FLEXING OF THE CABLE OVER TIME. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7880086) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK (REV. G), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. G), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE DRIVELINE POWER FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. G) 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". SECTION 8 "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE") 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." HEARTMATE 3 LVAS PATIENT HANDBOOK (REV. G) 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. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." 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 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.

    Additional Manufacturer Narrative · 0

    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 REPORTED THAT THE PATIENT HAS A DRIVELINE POWER FAULT. A MODULAR CABLE EXCHANGE WAS PERFORMED ON (B)(6) 2023 AND THERE WERE NO FURTHER ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444250 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 7880086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown