BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR (ASSIST) BYPASS

    MDR report key: 16662668 · Received April 3, 2023

    Report

    Report Number
    16662668
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    August 4, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE HELPING TO PREPARE A PATIENT WITH AN LVAD FOR TRAVEL TO GI SUITE, WHILE CONNECTING THE CONTROLLER'S WHITE POWER CABLE TO THE LITHIUM ION BATTERY, A "CONNECT POWER" MESSAGE APPEARED IN THE DISPLAY WINDOW OF THE SYSTEM CONTROLLER AS WELL AS A YELLOW LIGHT WAS ILLUMINATED INDICATING THE WHITE POWER CABLE WAS NOT CONNECTED. ALTHOUGH IT APPEARED PHYSICALLY CONNECTED. I FIRST REPLACED THE BATTERY CLIP AND WHEN THE WHILE CABLE WAS MANIPULATED AGAIN THE SAME MESSAGE APPEARED. BRIEFLY. I FELT THIS WAS UNSAFE FOR THE PATIENT, SO I PROCEEDED TO REPLACE THE CONTROLLER WITHOUT INCIDENT. THE NEW CONTROLLER. IT WILL BE SENT BACK TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506035 VENTRICULAR (ASSIST) BYPASS DSQ ABBOTT VASCULAR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30295 DA Female