BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 23478420 · Received November 5, 2025

    Report

    Report Number
    2916596-2025-07241
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 6, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE ALARMS BEING QUIETER THAN EXPECTED WAS UNABLE TO BE CONFIRMED. THE PROVIDED LOG FILES FOR BOTH THE ORIGINAL AND REPLACEMENT CONTROLLER WERE REVIEWED; HOWEVER, THE LOG FILE DOES NOT CONTAIN INFORMATION REGARDING THE AUDIBILITY OF THE CONTROLLER¿S ALARMS. THE PUMP OPERATED AS INTENDED WHILE CONNECTED TO THE DRIVELINE, AND ALL OBSERVED ALARMS WERE CONSISTENT WITH SYSTEM CONTROLLER EXCHANGE. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (REV. D) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESS HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. THE HEARTMATE 3 LVAS IFU (REV. D) SECTION 10 ENTITLED ¿SAFETY CHECKLISTS¿ AND THE HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION F ENTITLED ¿SAFETY CHECKLISTS¿ INSTRUCT USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLERS, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. HEARTMATE 3 PATIENT HANDBOOK (REV. D) 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PERFORMED A SYSTEM CONTROLLER EXCHANGE DUE TO EXPERIENCING LOW AUDIBLE ALARMS FROM THE SYSTEM CONTROLLER DURING A SELF-TEST. THE PATIENT PRESENTED TO CLINIC IN WHICH THE AFFECTED SYSTEM CONTROLLER WAS CONNECTED TO A SIMULATOR AND A SELF-TEST WAS PERFORMED. THE CLINICIANS NOTED THAT THE ALARMS SOUNDED NORMAL DURING THE TEST. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILE FROM THE PREVIOUSLY CONNECTED SYSTEM CONTROLLER INDICATED THAT THERE WERE NO ISSUES PRIOR TO THE SYSTEM CONTROLLER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491594 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US L00000283 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male