BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18409129 · Received December 28, 2023

    Report

    Report Number
    2916596-2023-08699
    Event Type
    Death
    Date Received
    December 28, 2023
    Date of Event
    December 6, 2023
    Report Date
    April 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE DISCONNECTS AND SUBSEQUENT PUMP STOP EVENTS WHICH THE ACCOUNT ATTRIBUTED TO THE PATIENT BEING CONFUSED AND DISCONNECTING EVERYTHING. EVALUATION OF THE SUBMITTED CONTROLLER EVENT LOG FILE REVEALED THAT THE DRIVELINE WAS BRIEFLY DISCONNECTED MULTIPLE TIMES ON (B)(6) 2023 CAUSING THREE PUMP STOPS. THE DRIVELINE WAS OBSERVED TO HAVE BEEN DISCONNECTED AGAIN AND REMAINED DISCONNECTED FOR THE REMAINDER OF THE FILE. THIS WAS CONSISTENT WITH THE REPORTED EVENT THAT THE PATIENT WAS CONFUSED AND WAS DISCONNECTING EVERYTHING. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED WHILE THE DRIVELINE WAS CONNECTED. ADDITIONAL INFORMATION REVEALED THAT THE CAUSE OF DEATH WAS NOT IDENTIFIED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HM 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "SYSTEM CONTROLLER WARNINGS AND CAUTIONS"), STATES ¿IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION." ADDITIONALLY, SECTION 2 OF THE IFU, UNDER "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 6 ALSO 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 2 OF THE PATIENT HANDBOOK, ¿HOW YOUR HEART PUMP WORKS¿, ALSO ADVISES THE USER TO ¿CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION¿. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 5 OF THE PATIENT HANDBOOK ALSO CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. FURTHERMORE, THE HANDBOOK CAUTIONS USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ 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 MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE. THE PATIENT HAD NO ADVERSE EFFECTS DIRECTLY AFTER THE CHANGE, INTERNATIONAL NORMALIZED RATIO (INR) OF 2.7, AND WAS MONITORED FOR HOURS PRIOR TO BEING DISCHARGED HOME. PER THE PATIENT'S FAMILY, THE PATIENT STARTED HAVING ALARMS AT HOME AND SEEMED CONFUSED. THE PATIENT ATTEMPTED TO CHANGE THEIR BATTERIES BUT WAS REPORTEDLY DISCONNECTING EVERYTHING AND COULD NOT FIGURE OUT WHAT TO CONNECT AFTER. THE PATIENT LOST CONSCIOUSNESS AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED. EMS PERFORMED CHEST COMPRESSIONS HOWEVER THE PATIENT EXPIRED. LOG FILES WERE SUBMITTED FOR REVIEW TO GET AN IDEA OF WHAT HAPPENED PRIOR TO ARREST. THE LOG FILES CAPTURED MULTIPLE NO EXTERNAL POWER ALARMS AND DRIVELINE DISCONNECTS ON (B)(6) 2023. THERE DID NOT APPEAR TO BE ANY ALARMS LEADING UP TO THE NO EXTERNAL POWER ALARMS AND DRIVELINE DISCONNECTS. THE NO EXTERNAL POWER ALARMS WERE DETERMINED TO BE DUE TO THE PATIENT DISCONNECTING BOTH SYSTEM CONTROLLER LEADS FROM POWER. AT 3:00 PM ON (B)(6) 23023 THE DRIVELINE WAS DISCONNECTED WITHOUT RECONNECTION. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08700 (NEW SYSTEM CONTROLLER). RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08701 (EXCHANGED SYSTEM CONTROLLER). RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08703 (EXCHANGED MODULAR CABLE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE DUE TO DRIVELINE DAMAGE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274054 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6780830 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death