BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 21806190 · Received April 9, 2025

    Report

    Report Number
    2916596-2025-02060
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 5, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    SECTION D9: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE MODULAR CABLE, LOT 9173976, WAS RETURNED FOR EVALUATION FOLLOWING THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS. DATA FROM THE REPORTED EVENT DATE OF 18MAR2025 IN THE SUBMITTED CONTROLLER EVENT LOG FILE (B)(6) WAS REVIEWED. ON 18MAR2025 WHILE CONNECTED TO BATTERIES, THE DRIVELINE POWER FAULT ALARM WAS ACTIVE DUE TO A POWER A BROKEN AND OCP A BROKEN FAULTS. THE ALARM LASTED THROUGH THE REMAINDER OF THE LOG FILE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. DATA FROM THE REPORTED EVENT DATE OF 18MAR2025 IN THE SUBMITTED CONTROLLER EVENT LOG FILE (B)(6) POST EXCHANGE WAS REVIEWED. AFTER THE NEW SYSTEM CONTROLLER AND MODULAR CABLE WERE CONNECTED TO THE PUMP, THERE WERE NO ALARMS ACTIVE. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED MODULAR CABLE WAS FUNCTIONALLY TESTED WITH THE RETURNED SYSTEM CONTROLLER AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS; NO ALARMS WERE PRODUCED. THE CABLES INTERNAL CONDUCTORS WERE ALSO TESTED, AND NO ANOMALIES WERE NOTED. THE PROVIDED INFORMATION STATED THAT THE PATIENT WAS USING SCISSORS TO CUT OFF A DRIVELINE ANCHOR AND ACCIDENTLY SLICED THEIR PUMP CABLE. THE ALARM RESOLVED AFTER THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE EXCHANGE RESOLVED THE EVENT DUE TO THE ALARM LATCHING AND NOT CLEARING UNTIL A NEW CONTROLLER WAS CONNECTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. PER THE PROVIDED INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT WAS DUE TO USER ERROR BY CUTTING THEIR PUMP CABLE. THE REPORTED EVENT COULD NOT BE CORRELATED TO AN ISSUE WITH THE RETURNED MODULAR CABLE. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT DRIVELINE POWER FAULT ALARMS. THE HEARTMATE 3 LVAS PATIENT HANDBOOK (REV D) SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE AND PROPER SHOWERING METHODS IN SECTION 4 ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "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." 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 CALLED AND NOTED A DRIVELINE POWER FAULT ALARM. THE PATIENT STATED THEY WERE USING SCISSORS TO CUT OFF A DRIVELINE ANCHOR AND ACCIDENTALLY SLICED THEIR DRIVELINE PROXIMAL TO THE MODULAR CABLE CONNECTION. THE PATIENT'S DAUGHTER STATED THAT THE DRIVELINE CUT HAD OCCURRED THAT MORNING. THE LOG FILES WERE REVIEWED AND CAPTURED A SYSTEM CONTROLLER INTERNAL FAULT/DRIVELINE POWER FAULT STARTING ON 18MAR2025 WHICH CONTINUED THE REMAINDER OF THE LOG FILE. IT WAS ALSO NOTED THAT THE FUSE WAS OPEN AS WELL, WHICH MEANT THAT THE SCISSORS NICKED THE GROUND AND POWER WIRES RESULTING IN THE FUSE IN THE SYSTEM CONTROLLER BEING BLOWN. A SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGE WERE SUGGESTED TO SEE IF THE ALARMS RETURN. IN LOOKING AT THE PHOTOS IT APPEARED THAT THE SCISSORS MADE IT THROUGH THE KEVLAR LAYER AND HAD BREACHED THE UNDERLYING WIRES. IT WAS NOTED THAT TECH SERVICES MAY NEED TO GO ONSITE TO APPLY SOME TAPE OR REATTACH WIRING. THE LOG FILES WERE SENT IN AGAIN AFTER PERFORMING 30 DISCONNECTS/RECONNECTS WITH THE BLACK POWER CABLE. A NEW SYSTEM CONTROLLER AND MODULAR CABLE WERE GIVEN TO THE PATIENT. NO FURTHER DRIVELINE POWER FAULT ALARMS WERE NOTED. THE LOG FILES WERE REVIEWED AND APPEARED THAT THE EQUIPMENT WAS FUNCTIONING AS INTENDED WITH NO ALARMS. IT WAS SUGGESTED THAT RESCUE TAPE BE PUT ON THE AREA OF DAMAGE UNTIL TECH SERVICES COULD COME AND WRAP IT IN SOME NON-CONDUCTIVE TAPE. THERE WAS WIRE REPAIR DONE FOR THE NICKED DRIVELINE THAT WAS CAUSING DRIVELINE FAULT EVENTS.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE DRIVELINE REPAIR WAS DONE ON (B)(6) 2025 AND THE COMPROMISED WIRE WAS TAPED UP. AFTER EXPOSING THE DAMAGED AREA, THE BLACK AND BROWN WIRES BOTH HAD SUPERFICIAL CUTS IN THE INSULATION SHOWING THE WIRE STRANDS. BOTH WIRES WERE WRAPPED IN NON-CONDUCTIVE TAPE AND THE WHOLE AREA WAS RETAPED USING RESCUE TAPE. THERE WERE NO FAULTS NOTED PRIOR OR AFTER REPAIR OF THE WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492041 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9173976 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male