BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23493066 · Received November 6, 2025

    Report

    Report Number
    2916596-2025-07272
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 23, 2025
    Report Date
    February 9, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G3: DATE RECEIVED BY MANUFACTURER OF THE PREVIOUS REPORT WAS 05NOV2025. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED PUMP STOP EVENTS DUE TO THE DISCONNECTION OF THE DRIVELINE. THE CONTROLLER EVENT LOG FILES COLLECTIVELY CONTAINED EVENTS FROM 05FEB2000 THROUGH 06AUG2000 AND 23OCT2025 THROUGH 30OCT2025. THE FILE CAPTURED SEVEN PUMP STOPS DUE TO DRIVELINE DISCONNECTS ON 05FEB2000, 11FEB2000, 17FEB2000, AND 18FEB2000. A SPECIFIC CAUSE FOR THESE EVENTS WAS UNABLE TO BE DETERMINED THROUGH THIS INVESTIGATION. THE FILE CAPTURED AN ADDITIONAL FIVE PUMP STOPS DUE TO DRIVELINE DISCONNECTS ON 23OCT2025, 24OCT2025, 26OCT2025, 29OCT2025, AND 30OCT2025. THE ACCOUNT ATTRIBUTED THESE DISCONNECTIONS TO THE PATIENT¿S NON-COMPLIANCE. THE PATIENT WAS NOT SUICIDAL BUT WAS AWARE OF WHAT THEY WERE DOING. EACH TIME, THE DRIVELINE WAS RECONNECTED, AND THE PUMP RAMPED BACK UP TO THE SET SPEED WITHOUT ISSUE. THE PUMP APPEARED TO OPERATE AS EXPECTED WHILE THE DRIVELINE WAS CONNECTED. INCIDENTAL FINDINGS: AN ADDITIONAL 39 SOFTWARE RESETS, NOT ASSOCIATED WITH THE EVENTS CAPTURED THE IN THE CONTROLLER EVENT LOG FILE, WERE CAPTURED IN THE LVAD EVENT LOG FILE FROM 23AUG2025 THROUGH 30OCT2025. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-042312, WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-042312 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "SYSTEM CONTROLLER WARNINGS AND CAUTIONS"), STATES, "CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. 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 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¿. THE PATIENT HANDBOOK ALSO EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. FURTHERMORE, SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", AND SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", ADDRESS SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES,¿ ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE PATIENT HANDBOOK ALSO INSTRUCTS 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. THE CURRENT REVISION OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A4 - PATIENT WEIGHT PATIENT WEIGHT NOT PROVIDED BY CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERROGATION OF THE PATIENT'S SYSTEM CONTROLLER SHOWED MULTIPLE PUMP OFF, DRIVELINE DISCONNECTED, LOW FLOW, AND NO EXTERNAL POWER EVENTS FROM 29OCT TO 30OCT. THE PATIENT NOTED THEY DID NOT SEE OR HEAR ANY ALARMS DURING THESE EVENTS. LOG FILES WERE SUBMITTED FOR EVALUATION. LOG FILE REVIEW BY TECH SERVICES APPEARED TO RECORD A SEQUENCE OF EVENTS ON 23OCT2025 INDICATING THAT THE EXTERNAL POWER AND DRIVELINE WERE INTENTIONALLY DISCONNECTED WHICH LED TO THE CONTROLLER SHUTTING DOWN, AND THAT THE ALARM SILENCE BUTTON WAS PRESSED DURING THESE EVENTS. SIMILAR SEQUENCES OF THESE EVENTS ALSO OCCURRED ON 24OCT2025 (CONTROLLER SHUTDOWN @1448, DRIVELINE RECONNECTED @1744), 26OCT2025 (CONTROLLER SHUTDOWN @0926, DRIVELINE RECONNECTED 27OCT2025 @1138), AND 29OCT2025 (CONTROLLER SHUTDOWN @1504, DRIVELINE RECONNECTED @1749). A NO EXTERNAL POWER EVENT WAS RECORDED ON 30OCT2025 @0706 WITH UNUSUAL VOLTAGES, SUGGESTING AN ISSUE THE PATIENT CABLE. A DRIVELINE DISCONNECT EVENT WAS RECORDED ON 30OCT2025 @0708 AND RECONNECTED @0709. IT WAS LATER REPORTED THAT THE PATIENT'S BACKUP CONTROLLER (B)(6) CONTAINED CONTROLLER CLOCK CORRUPT ALARMS FROM (B)(6) 2000. SINCE THE CONTROLLER CLOCK RESETS TO (B)(6) 2000 WHEN POWER IS LOST, THE CLOCK CORRUPT ALARM AND LOSS OF POWER OCCURRED APPROXIMATELY 8 MONTHS AND 7 DAYS AGO.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PUMP STOP EVENTS WERE DUE TO PATIENT NON-COMPLIANCE. THERE WERE NO ADVERSE PATIENT IMPACTS FROM THE REPORTED EVENTS. NONE OF THE PATIENT'S DEVICES WERE EXCHANGED. THE PATIENT WAS ADMITTED INTO CARE WITH VOLUME OVERLOADED DUE TO NOT TAKING HEART FAILURE MEDICATION AND WAS DISCHARGED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186081 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10237509 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male