BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 13107708 · Received December 29, 2021

    Report

    Report Number
    2916596-2021-07443
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 9, 2021
    Report Date
    March 11, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 A BACKUP BATTERY FAULT WAS CONFIRMED VIA ANALYSIS OF THE DOWNLOADED LOG FILE. THE LOG FILE CONTAINED INFORMATION SPANNING APPROXIMATELY 4 DAYS (B)(6) 2021 TO (B)(6) 2021 PER TIMESTAMP). AT 2:35 ON (B)(6) 2021, A BACKUP BATTERY FAULT WAS ACTIVATED DUE TO THE BACKUP BATTERY FAILING THE LOAD TEST. AT THIS TIME, THE UNLOADED VOLTAGE WAS OBSERVED TO BE BELOW THE DESIGNED THRESHOLD, ACTIVATING THE ALARM. THE FAULT DID NOT IMPACT THE ABILITY OF THE PUMP TO MAINTAIN A SPEED ABOVE THE LOW SPEED LIMIT. THE ALARM REMAINED ACTIVE UNTIL THE CONTROLLER WAS FULLY SHUT DOWN SOMETIME AFTER 10:53 ON (B)(6) 2021. THERE WERE NO OTHER NOTABLE EVENTS IN THE LOG FILE. THE HEARTMATE 3 SYSTEM CONTROLLER (HSC-033475) WAS EXCHANGED AND RETURNED FOR ANALYSIS. THE SYSTEM CONTROLLER PASSED EACH STEP OF THE PRELIMINARY AND FUNCTIONAL TESTING PROCEDURES WITHOUT ISSUE AND ATYPICAL ALARMS WERE UNABLE TO BE REPRODUCED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. BACKUP BATTERY FAULT ALARMS CAUSED BY LOAD TEST FAILURE CONDITIONS ARE BEING ADDRESSED VIA A CORRECTIVE ACTION. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES INSTRUCTION ON THE APPROPRIATE ACTIONS TO TAKE WHEN RESOLVING ALARMS THAT SOUND FROM THEIR CONTROLLER, INCLUDING BACKUP BATTERY FAULT ALARMS. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 "EQUIPMENT MAINTENANCE" DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ENTITLED ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER FOR DAMAGE. THE PATIENT HANDBOOK ALSO 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 THAT THE PATIENT'S SYSTEM CONTROLLER CONTINUED TO ALARM FOR BACK-UP BATTERY FAULT DESPITE A NEW FULLY FUNCTIONING BACK-UP BATTERY BEING IN USE. THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002364 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531INT 7123904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown