BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 16609475 · Received March 24, 2023

    Report

    Report Number
    16609475
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 22, 2023
    Manufacturer
    SVS LLC
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BAG DEFLATED ABOUT 2 HOURS AFTER THE MITRAL CLIP CASE STARTED. USER COULD NOT PUMP AIR INTO IT AND COULD HEAR IT JUST LEAKING INTO THE ROOM W/EACH PUMP. THERE WAS ENOUGH PRESSURE ON THE BAG THAT THE USER COULDN'T REMOVE THE SALINE BAG FROM THE PRESSURE BAG. GRABBED A NEW BAG TO PRESSURIZE. MANUFACTURER RESPONSE FOR 1000CC PRESSURE BAG, (BRAND NOT PROVIDED) (PER SITE REPORTER). TOOK DESCRIPTION OF PROBLEM, ISSUE RGA#: 23-148.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520534 PREMIERPRO INFUSOR, PRESSURE, FOR I.V. BAGS KZD SVS LLC 8818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown