BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 15248553 · Received August 18, 2022

    Report

    Report Number
    2916596-2022-12923
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    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: 162729) WAS RETURNED FOR ANALYSIS AND A LOG WAS SUBMITTED AND DOWNLOADED FROM THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) FOR REVIEW. A REVIEW OF THE LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 37 DAYS ((B)(6) 2019 ¿ (B)(6) 2022, (B)(6) 2000, (B)(6) 2022, (B)(6) 2022 PER TIMESTAMP). EVENTS OCCURRING BETWEEN (B)(6) 2019 ¿ (B)(6) 2022, AND ON ( B)(6) "2000" WERE RECORDED WHILE THE CONTROLLER WAS BEING CHARGED. THE CONTROLLER WAS THE PATIENT¿S BACKUP CONTROLLER DURING THIS TIME AND THE DRIVELINE WAS NOT CONNECTED. EVENTS OCCURRING ON (B)(6) 2022 WERE RECORDED DURING TESTING AT ABBOTT. INTERMITTENT DRIVELINE POWER FAULT ALARMS THAT WERE CORRELATED WITH FUSE B BEING OPEN WERE ACTIVE UPON CONNECTION OF THE DRIVELINE TO THE SYSTEM CONTROLLER ON (B)(6) 2022 AT 14:33:10 AND CONTINUED UNTIL (B)(6) 2022 AT 08:07:24. PUMP OPERATION WAS NOT AFFECTED BY THESE ALARMS. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AT 08:07:25 FOR A SYSTEM CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED MODULAR CABLE (LOT NUMBER: 162729) WAS CONNECTED TO THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) AND A MOCK LOOP. UPON CONNECTION TO THE CONTROLLER A DRIVELINE POWER FAULT ALARM ACTIVATED. THE MODULAR CABLE WAS THEN TESTED PER QAP, MODULAR CABLE TEST TO EVALUATE THE INTEGRITY OF ITS WIRES AND PASSED TESTING. THE OUTER JACKET WAS STRIPPED, AND MULTIPLE KINKS WERE NOTED ALONG THE CABLE. FURTHER VISUAL ANALYSIS OF THE CABLE'S UNDERLYING WIRES REVEALED BREAKS TO THE CABLE'S BROWN WIRE (POWER A) WIRE, AS WELL AS KINKS TO OTHER WIRES AT THE SITES OF BREAKAGE ON THE BROWN WIRE. 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 WIRES; HOWEVER, A ROOT CAUSE FOR THE DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 162729) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) 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) 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL IN THE WATER. LOG FILES SHOWED THAT THE PATIENT WAS ON (B)(4) AT THE TIME OF HER FALL INTO THE WATER. LOG FILE REVIEW FOR (B)(4) CAPTURED POWER CABLE DISCONNECTS, LOW POWER HAZARDS, AND LOW POWER ADVISORY ALARMS THROUGHOUT THE LOG FROM (B)(6) 2022 15:10 - 15:20. THE DRIVELINE WAS DISCONNECTED FROM THE CONTROLLER AT 15:20. THE PATIENT SWITCHED TO (B)(4) WHICH WAS HER BACKUP CONTROLLER. ON (B)(6) 2022 THE PATIENT PRESENTED TO THE CLINIC AND DRIVELINE POWER FAULT ALARMS WERE NOTED UPON ARRIVAL. THE ALARM WAS CLEARED AND IMMEDIATELY RETURNED. RESCUE TAPE WAS NOTED ALONG THE ENTIRE LENGTH OF THE MODULAR CABLE. LABS AND ECHOCARDIOGRAM WERE OBTAINED. LOG FILE REVIEW FOR (B)(4) SHOWED THAT UPON CONNECTION TO THE DRIVELINE ON (B)(6) 2022 AT 14:33 THE LOG IMMEDIATELY CAPTURED DRIVELINE POWER FAULT WITH F5, POWER B OPEN FAULT AND F3 POWER B FUSE OPEN FAULT OCP-B, OVERCURRENT ON B FUSE. THE MODULAR CABLE AND SYSTEM CONTROLLER ((B)(4) WERE EXCHANGED IN CLINIC AND THE DRIVELINE POWER FAULT ALARMS RESOLVED. THE PATIENT WAS GIVEN TWO NEW SYSTEM CONTROLLERS, A NEW MODULAR CABLE, NEW BATTERY CLIPS, AND FOUR CURRENT BATTERIES MAY ALSO BE REPLACED OUT OF PRECAUTION (THE PATIENT DID NOT RECALL WHICH BATTERIES SHE WAS ON AT THE TIME OF THE FALL INTO THE WATER). THE PATIENT WAS ASYMPTOMATIC AND DOING WELL. RELATED MFR #S: 2916596-2022-12837, 2916596-2022-12924.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245230 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 162729 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female