BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER PRO

    MDR report key: 6546073 · Received May 4, 2017

    Report

    Report Number
    6546073
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 11, 2017
    Manufacturer
    S2S GLOBAL
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    1. PRESSURE BAGS OVER INFLATE (AFTER THEY ARE HANGING FOR A WHILE) AND CAUSE THE FLUID BAG TO RUPTURE AND SPRAY/LEAK. 2. PREMIER PRO 1 LITER PRESSURE BAGS (REORDER NUMBER (B)(4)) DO NOT ENCOMPASS THE ENTIRE LITER BAG OF SALINE. WHEN PUMPED UP TO 300 MMHG, THE SALINE BAGS ARE BURSTING. 3. THE PRESSURE GAUGE OFTEN DID NOT ENGAGE UNTIL THE BAG WAS FILLED/OVERFILLED AND THEN WOULD POP OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324390 PREMIER PRO INFUSOR, PRESSURE, FOR I.V. BAGS KZD S2S GLOBAL 8801

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR