BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA VISIV

    MDR report key: 1050091 · Received May 20, 2008

    Report

    Report Number
    MW5006978
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    March 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERAL 1 LITER HOSPIRA BRAND VISIV BAGS WERE DISCOVERED TO LEAK AT THE "SEAM" AT THE TOP OF THE BAG. THIS WAS DISCOVERED IN A STORAGE LOCATION. THE HOSPITAL REPORTED THE PROBLEM TO THE MFR AT THAT TIME. SEVERAL WEEKS LATER, MORE BAGS, DELIVERED AFTER THE REPORT, WERE FOUND TO HAVE THE SAME PROBLEM. NONE OF THE BAGS WERE USED ON PATIENTS. A HOSPIRA QA REPRESENTATIVE IS COMING TO RESEARCH THE PROBLEM AND DISCUSS RESOLUTION. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA VISIV VISIV 1 LITER FLUID BAGS KPE HOSPIRA MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1