BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23770693 · Received December 10, 2025

    Report

    Report Number
    2916596-2025-07810
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 9, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE POWER FAULT ALARMS THAT APPEAR CONSISTENT WITH A FLUID INGRESS ISSUE AT THE CONNECTION BETWEEN THE PUMP CABLE AND MODULAR CABLE. RESIDUE INDICATIVE OF OXIDATION FROM FLUID INGRESS WAS CONFIRMED VIA EVALUATION OF THE RETURNED MODULAR CABLE (REFER TO PI-2025-0191349-03). HOWEVER, FLUID INGRESS ON THE PUMP CABLE SIDE WAS UNABLE TO BE CONFIRMED AS NO IMAGES OF THE INLINE CONNECTOR WERE PROVIDED, AND THE DEVICE REMAINS IN USE. THE SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED A DRIVELINE POWER FAULT ALARM ASSOCIATED WITH INTERMITTENT POWER B BROKEN FAULTS FROM 25NOV2025 ¿ 26NOV2025. THE ONSET AND RESOLUTION OF THE ALARM WERE NOT CAPTURED. THE ADDITIONAL CONTROLLER EVENT LOG FILE SUBMITTED FOLLOWING THE MODULAR CABLE AND CONTROLLER EXCHANGE CAPTURED THE DRIVELINE POWER FAULT ALARM ACTIVATING AGAIN ON 01DEC2025 AFTER THE DRIVELINE WAS RECONNECTED TO THE NEW CONTROLLER. THE RESOLUTION OF THE ALARM WAS NOT CAPTURED IN THE FILE. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO BE OPERATING AS INTENDED AT THE STORED PATIENT SPEED WHILE THE DRIVELINE WAS CONNECTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), WITH NO FURTHER RELATED EVENTS REPORTED AT THIS TIME. 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 SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. A, ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS SYSTEM ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS, AS WELL AS THE RECOMMENDED ACTIONS ASSOCIATED WITH EACH. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER FAULT ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER 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 IFU AND PATIENT HANDBOOK PROVIDE INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE AND INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE. THE IFU AND PATIENT HANDBOOK ALSO INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID. 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 WAS BROUGHT TO THE CLINIC TO DOWNLOAD LOG FILES AND PERFORM A MODULAR CABLE REPLACEMENT DUE TO A DRIVELINE POWER FAULT. THE HEALTHCARE PROVIDER DID NOT ATTEMPT TO CLEAR THE ALARM, THE LAST TRY TO CLEAR THE ALARM WAS IN MAY2025 WHICH INITIALLY SILENCED THE EVENT, BUT IT REOCCURRED IN THREE HOURS THAT THEN PROMPTED THE IN-PERSON ABBOTT ENGINEER TEAM TO CLEAN THE MODULAR CABLE CONNECTION WHICH THEN CLEARED THE ALARM UNTIL THE DATE OF THIS EVENT. THE HEALTHCARE PROVIDER THEN PERMANENTLY SILENCED THE ALARM. THERE WAS NO OBVIOUS EXTERNAL DAMAGE TO THE DRIVELINE OF THE MODULAR CABLE INTERFACE, AND THE PATIENT WAS HEMODYNAMICALLY STABLE. THE LOG FILE CAPTURED NEW DRIVELINE POWER FAULT ALARMS BEGINNING ON (B)(6) 2025. THE PLAN WAS TO HAVE THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL TO CLEAR THE ALARMS AND REPLACE THE MODULAR CABLE. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. ADDITIONAL LOG FILES WERE SUBMITTED THAT SHOWED ON (B)(6) 2025, MULTIPLE DRIVELINE POWER FAULTS (PWR B). THE MODULAR CABLE AND CONTROLLER HAD BEEN REPLACED TO TRY AND RESOLVE THE ISSUE, AND A REPLACEMENT WAS REQUESTED. IT WAS ADDITIONALLY COMMUNICATED THAT ISOPROPYL ALCOHOL WAS USED TO REMOVE DEBRIS FROM THE PUMP SIDE OF THE CONNECTOR. THE CLEANING PROCEDURE RESOLVED THE DRIVELINE POWER FAULT B ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043060 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00001946 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male