BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 24072377 · Received January 14, 2026

    Report

    Report Number
    2916596-2026-00215
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 26, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q325-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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: THE REPORTED EVENT OF A BACKUP BATTERY FAULT WAS CONFIRMED VIA REVIEW OF THE LOG FILES. DATA FROM THE REPORTED EVENT DATES 05JAN2026 WAS REVIEWED FOR THE SUBMITTED AND DOWNLOADED LOG FILES. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE THROUGHOUT THE REPORTED EVENT DATE. THE CONTROLLER EVENT LOG FILES REVEALED A BACKUP BATTERY FAULT ALARM ON 4:46:42. THE ALARM CONTINUED TO BE INTERMITTENTLY ACTIVE FOR THE REMAINING DURATION OF LOG FILE. THE ALARM IS ASSOCIATED WITH THE BACKUP BATTERY NOT PASSING THE LOAD TEST. THE BACKUP BATTERY DID NOT PASS THE INITIAL LOAD TEST DUE TO THE LOADED VOLTAGE MEASURING UNDER THE ACCEPTABLE THRESHOLD COMPARED TO THE UNLOADED VOLTAGE. WHEN THE BACKUP BATTERY INITIALLY DID NOT PASS THE LOAD TEST, THE LOADED VOLTAGE MEASURED TO BE 11.361V, AND THE UNLOADED VOLTAGE MEASURED TO BE 12.171V. THE DRIVELINE WAS DISCONNECTED AT 11:08:05, CONSISTENT WITH THE REPORTED CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE THROUGHOUT THE REPORTED EVENT DATE. PUMP OPERATION WAS NOT AFFECTED. THE SYSTEM CONTROLLER (B)(6) WAS RETURNED FOR TESTING. THE CONTROLLER FUNCTIONED AS INTENDED THROUGHOUT TESTING AND SUPPORTED THE SYSTEM WITHOUT ISSUES OR ALARMS. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. A CORRECTIVE ACTION WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. THE HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT. SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, DESCRIBES THE VISUAL AND AUDIBLE ALARMS ASSOCIATED WITH THE BACKUP BATTERY FAULTS AND HOW TO RESOLVE THEM. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 2, ENTITLED ¿SYSTEM OPERATIONS¿, INCLUDES HOW TO PERFORM A SELF-TEST ON THE SYSTEM CONTROLLER. IT NOTES THE IMPORTANCE OF DOING THE TEST DAILY TO ENSURE ALARMS ARE FUNCTIONAL. THE HEARTMATE 3 PATIENT HANDBOOK (REV. A) WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT AND 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. 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 BACKUP BATTERY (EBB) FAULT IN DEC2025 THAT RESOLVED AFTER RESEATING THE EBB (CS-221335). THE ALARM RETURNED AND COULD NOT BE CLEARED SO THE SYSTEM CONTROLLER WAS EXCHANGED. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED EBB FAULTS STARTING AT 0446 ON 05JAN2026 AND CONTINUED ON AND OFF FOR THE REMAINDER OF THE LOG. IT APPEARED THAT THE FAULTS WERE DUE TO THE EBB FAILING THE LOAD TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132560 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US L00002882 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female