BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18507450 · Received January 12, 2024

    Report

    Report Number
    2916596-2024-00305
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    January 9, 2024
    Report Date
    June 27, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME WAS CORRECTED. SECTION D4: UDI, MODEL NUMBER, LOT NUMBER, AND EXPIRATION DATE WAS CORRECTED. MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DIFFICULTY ENGAGING THE MODULAR CABLE WAS NOT ABLE TO BE CONFIRMED. THE PATIENT REMAINS ONGOING ON THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 8941025. NO PRODUCT AVAILABLE FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT NUMBER 8941025 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 2, "SYSTEM OPERATIONS" STATES "CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION." SECTION 2 OF THE IFU, UNDER "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 6 ¿PATIENT CARE AND MANAGEMENT (UNDER "EDUCATING AND TRAINING PATIENTS, FAMILIES, AND CAREGIVERS") EXPLAINS THAT DURING THE PATIENT SELECTION, PREIMPLANT, AND POSTOPERATIVE PERIOD, THE PATIENT MUST RECEIVE INSTRUCTIONS REGARDING THE OPERATION AND CARE OF EVERY SYSTEM COMPONENT (INCLUDING THE DRIVELINE AND WHAT TO DO IN AN EMERGENCY). THE PATIENT HANDBOOK WARNS "THE PUMP WILL STOP IF THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, RECONNECT IT RIGHT AWAY TO RESTART THE PUMP. THE PUMP CANNOT RUN WITHOUT POWER." THE PATIENT HANDBOOK WARNS ¿DO NOT DISCONNECT THE MODULAR IN-LINE CONNECTOR OR THE PUMP WILL STOP.¿ IN ADDITION, THE PATIENT HANDBOOK STATES, "CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT." THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES. 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

    THE PATIENT HAD TROUBLE LINING UP THE DOTS CORRECTLY. ONCE THE PATIENT WAS ABLE TO LINE UP THE DOTS, THE DRIVELINE WAS CONNECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR EVALUATION CONCERNING A BACKUP BATTERY FAULT ALARM. THE PATIENT WAS ASYMPTOMATIC, BUT THEY WERE ANXIOUS DUE TO THE ALARM, AND PERFORMED A SYSTEM CONTROLLER EXCHANGE AT HOME BEFORE CONTACTING AN ON-CALL COORDINATOR. THE PATIENT HAD TROUBLE GETTING THE DRIVELINE INSERTED INTO THE PORT. IT WAS ESTIMATED THAT A COUPLE MINUTES PASSED BEFORE THE PATIENT WAS ABLE TO INSERT THE DRIVELINE INTO THE NEW SYSTEM CONTROLLER. THERE WERE NO FURTHER ALARMS AFTER THE SYSTEM CONTROLLER EXCHANGE. THE LOG FILES SUBMITTED FOR THE NEW PRIMARY SYSTEM CONTROLLER IN USE CONFIRMED THAT WERE NO UNUSUAL ALARMS RECORDED AFTER THE CONTROLLER EXCHANGE. THE MECHANICAL CIRCULATORY EQUIPMENT WAS OPERATING AS INTENDED. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-00304.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100755 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 9150763 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male