BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 24349454 · Received February 16, 2026

    Report

    Report Number
    2916596-2026-00922
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 10, 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
    AR, 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF BACKUP BATTERY FAULT AND LOW VOLTAGE ALARMS WAS CONFIRMED VIA THE SUBMITTED AND DOWNLOADED LOG FILES BUT WAS NOT REPRODUCED DURING EVALUATION OF THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER. THE SUBMITTED AND DOWNLOADED CONTROLLER EVENT LOG FILES CONTAINED OVERLAPPING DATA FROM 07FEB2026 TO 09FEB2026 PER TIMESTAMP. THROUGHOUT THE LOG FILES, INTERMITTENT ATYPICAL LOW VOLTAGE ADVISORY ALARMS WERE CAPTURED WHILE CONNECTED TO 14V LI-ION BATTERIES DUE TO THE RELATIVE STATE OF CHARGE (RSOC) ON THE WHITE POWER CABLE FLUCTUATING BELOW THE ALARM THRESHOLDS. THE ALARMS RESOLVED WHEN THE RSOC VOLTAGE RETURNED TO THE EXPECTED VOLTAGE RANGE. ON 09FEB2026 FROM 8:56:06-8:58:59 AND 8:59:02-11:33:44, THE LOG FILES CAPTURED BACKUP BATTERY FAULT ALARMS DUE TO THE BACKUP BATTERY NOT PASSING THE LOAD TEST. THE LOAD TEST DID NOT PASS DUE TO THE LOADED VOLTAGE BEING OUTSIDE THE EXPECTED RANGE AS COMPARED TO THE UNLOADED VOLTAGE. THE ALARM BRIEFLY RESOLVED AFTER A LOAD TEST WAS PERFORMED BEFORE REACTIVATING. THE ALARM WAS THEN ACTIVE UNTIL THE CONTROLLER WAS SHUT DOWN. ON 09FEB2026 AT 11:33:17, THE DRIVELINE WAS DISCONNECTED FOLLOWED BY BOTH POWER CABLES. THE CONTROLLER WAS SHUT DOWN SHORTLY AFTER. THIS IS CONSISTENT WITH THE CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE EVENTS CAPTURED IN THE LOG FILES. THE RETUNED SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), PASSED ALL FUNCTIONAL TESTING PROCEDURES AND SUCCESSFULLY OPERATED IN A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD WITHOUT ISSUE. THROUGHOUT TESTING PROCEDURES, MULTIPLE LOAD TESTS WERE PERFORMED, AND NO ATYPICAL ALARMS WERE ABLE TO BE REPRODUCED. THE CONTROLLER POWER CABLES WERE MANIPULATED THROUGHOUT TESTING WITHOUT ATYPICAL ALARMS ACTIVATING. A ROOT CAUSE FOR THE REPORTED BACKUP BATTERY FAULT AND LOW VOLTAGE ALARMS WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. A CORRECTIVE ACTION WAS OPENED TO FURTHER INVESTIGATE BACKUP BATTERY FAULT ALARMS. INCIDENTAL FINDINGS: SUPERFICIAL DAMAGE TO THE OUTER JACKET OF THE WHITE POWER CABLE, FLUID INGRESS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEAL THAT THE HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, AND HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND RESOLVE BACKUP BATTERY FAULT AND LOW VOLTAGE ADVISORY ALARMS. SECTION 2 OF THE IFU, 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. THIS SECTION ALSO INSTRUCTS THE USER TO NOT SUBMERGE THE SYSTEM CONTROLLER IN WATER OR LIQUID AND TO KEEP THE CONTROLLER POWER CABLES AWAY FROM ANY LIQUID AS WELL. THIS SECTION ALSO INSTRUCTS USERS NOT TO TWIST, KINK, OR SHARPLY BEND THE CONTROLLER POWER CABLES. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A BACKUP BATTERY FAULT (EBB) ALARM THAT DID NOT CLEAR WITH A SELF TEST. THE SYSTEM CONTROLLER WAS EXCHANGED AS THIS WAS THE PATIENT'S 4TH EBB FAULT (CS-211335, CS-214469, CS-215820). LOG FILE REVIEW WAS REQUESTED WHICH REVEALED EBB FAULTS ON 09FEB2026 AND CONTINUING UNTIL THE END OF THE LOG FILE DUE TO THE EBB FAILING THE LOAD TEST. ADDITIONALLY RANDOM CONNECT POWER EVENT'S WHILE UTILIZING BATTERY POWER. IT WAS RECOMMENDED TO SEE IF ANY BATTERIES REQUIRED CALIBRATION. EXCHANGING THE SYSTEM CONTROLLER RESOLVED THE EBB ALARMS. THE SITE DID NOT ADDRESS THE UNUSUAL CONNECT TO POWER ALARMS AS THE PATIENT HAD LEFT THE CLINIC BEFORE ANY ACTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412392 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 10092866 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male