BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17321190 · Received July 13, 2023

    Report

    Report Number
    2916596-2023-04625
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 22, 2023
    Report Date
    September 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: NO DEVICE-RELATED ISSUES ASSOCIATED WITH THE PATIENT'S MODULAR CABLE WERE REPORTED BY THE ACCOUNT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT NUMBER 8854654 WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. ALTHOUGH NO ISSUES WERE REPORTED WITH THE MODULAR CABLE, THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK CONTAIN INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. FURTHERMORE, 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. 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 PRESENTED TO THE EMERGENCY DEPARTMENT WITH WIRE FATIGUE AND LOW FLOW ALARMS. THE ALARMS OCCURRED MULTIPLE TIMES DAILY. THE EVENT LOG CONFIRMED LOW FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170084 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8854654 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male