BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9848665 · Received March 18, 2020

    Report

    Report Number
    2916596-2020-01473
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    March 2, 2020
    Report Date
    June 23, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE COMMUNICATION FAULTS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS AND A DIRECT CORRELATION TO HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE FIRST SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED DRIVELINE COMMUNICATION FAULTS ASSOCIATED WITH COM B FAULTS THROUGHOUT THE LOG FILE WHICH WERE SILENCED. COMMUNICATION FAULTS WERE ALSO ACTIVE THROUGHOUT THE FIRST SUBMITTED CONTROLLER PERIODIC LOG FILE AND THE LVAD LOG FILES. OF NOTE, THE ACCOUNT ALSO SUBMITTED LOG FILES THAT CAPTURED DATA AFTER THE PATIENT¿S REPORTED CONTROLLER AND MODULAR EXCHANGES AND THE COMMUNICATION FAULTS DID NOT RESOLVE. THE ONSET OF THE DRIVELINE COMMUNICATION FAULTS WAS PREVIOUSLY ADDRESSED IN PER-(B)(4); CS-113015 AND AGAIN IN PER-(B)(4); CS-130483. THE ACCOUNT REPORTED THAT THE PATIENT HAS HAD A DRIVELINE COMMUNICATION FAULT FOR SOME TIME (REFER TO PER-(B)(4); CS-113015), WHICH HAS BEEN SILENCED. THE PATIENT¿S BACKUP CONTROLLER AND MODULAR CABLE WERE EXCHANGED, HOWEVER, THE ALARMS PERSISTED FOLLOWING THE EXCHANGE. THE PATIENT¿S MODULAR CABLE, LOT NUMBER 183274, WAS RETURNED FOR EVALUATION (INVESTIGATION UNDER PI-(B)(4)). THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS PATIENT HANDBOOK PROVIDES A LIST OF ALARMS AND THE PROPER ACTIONS ASSOCIATED WITH THEM. THIS HANDBOOK LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE COMMUNICATION FAULTS, AND WHAT ACTIONS TO TAKE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# G140113. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23AUG2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 LVAS IS 00813024013297. SECTION G3: CORRECTION UPDATED MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE COMMUNICATION FAULTS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS AND A DIRECT CORRELATION TO HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE FIRST SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED DRIVELINE COMMUNICATION FAULTS ASSOCIATED WITH COM B FAULTS THROUGHOUT THE LOG FILE WHICH WERE SILENCED. COMMUNICATION FAULTS WERE ALSO ACTIVE THROUGHOUT THE FIRST SUBMITTED CONTROLLER PERIODIC LOG FILE AND THE LVAD LOG FILES. OF NOTE, THE ACCOUNT ALSO SUBMITTED LOG FILES THAT CAPTURED DATA AFTER THE PATIENT¿S REPORTED CONTROLLER AND MODULAR EXCHANGES AND THE COMMUNICATION FAULTS DID NOT RESOLVE. THE ONSET OF THE DRIVELINE COMMUNICATION FAULTS WAS PREVIOUSLY ADDRESSED IN MFR # 2916596-2018-03072 AND AGAIN IN MFR # 2916596-2019-04947. THE ACCOUNT REPORTED THAT THE PATIENT HAS HAD A DRIVELINE COMMUNICATION FAULT FOR SOME TIME (REFER TO MFR # 2916596-2018-03072), WHICH HAS BEEN SILENCED. THE PATIENT¿S BACKUP CONTROLLER AND MODULAR CABLE WERE EXCHANGED, HOWEVER, THE ALARMS PERSISTED FOLLOWING THE EXCHANGE. THE PATIENT¿S MODULAR CABLE, LOT NUMBER 183274, WAS RETURNED FOR EVALUATION (ADDRESSED IN MFR # 2916596-2020-01501). THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS PATIENT HANDBOOK PROVIDES A LIST OF ALARMS AND THE PROPER ACTIONS ASSOCIATED WITH THEM. THIS HANDBOOK LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE COMMUNICATION FAULTS, AND WHAT ACTIONS TO TAKE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT HAS HAD A DRIVELINE COMMUNICATION FAULT FOR SOME TIME WITH THE HEARTMATE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312109 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention HEARTMATE 3 VAD MODULAR CABLE