BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 11754938 · Received April 30, 2021

    Report

    Report Number
    2916596-2021-01990
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 5, 2021
    Report Date
    June 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMM ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILE. A REVIEW OF THE SUBMITTED LOG FILE SPANNED APPROXIMATELY 13 DAYS ((B)(6) 2021¿(B)(6) 2021 PER TIME STAMP). ON (B)(6) 2021 AT 20:21 THE DRIVELINE COMMUNICATION FAULT ALARM ACTIVATED DUE TO A COM A FAULT. THE ALARM REMAINED ACTIVE THROUGH THE REMAINDER OF THE LOG FILE. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THERE WERE NO OTHER NOTABLE ALARMS IN THE LOG FILE. THE HEARTMATE3 VAD MODULAR CABLE, (BATCH/LOT 190296) WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. NO ATYPICAL ALARMS WERE PRODUCED DURING TESTING. A CONTINUITY TEST OF ALL SIGNAL WIRES WERE MEASURED TO BE WITHIN SPECIFICATION. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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. HEARTMATE3 INSTRUCTIONS FOR USE REV C) SECTION 7, ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE3 PATIENT HANDBOOK (REV C) SECTION 5, ¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN APPROPRIATE ACTIONS TO TAKE FOR ALL ALARMS INCLUDING THE DRIVELINE COMM FAULT ALARMS. HEARTMATE3 PATIENT HANDBOOK (REV C) SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-01991. IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE COMMUNICATION ALARM. CLEARING THE ALARM VIA THE SYSTEM MONITOR DID NOT RESOLVE THE ISSUE. THE MODULAR CABLE, CONTROLLER, AND BACKUP BATTERY WERE EXCHANGED AND THE ALARM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647635 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 190296

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR