BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASITE HORIZON PUMP IV SET

    MDR report key: 1010228 · Received March 10, 2008

    Report

    Report Number
    MW5005822
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 7, 2008
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    B BRAUN ULTRASITE HORIZON PUMP IV SET HAS PACKAGING THAT DOES NOT IDENTIFY THAT CASSETTE CONTAINS METAL AND THAT IV TUBING IS INCOMPATIBLE WITH MRI PROCEDURES. ALSO, THE TUBING HAS TWO VALVES. THE PACKAGING STATES THEY ARE 2 BACKCHECK VALVES, BUT AFTER BACKFLOW OF MEDICATION AND DISCUSSION WITH B BRAUN, FACILITY WAS TOLD THE HIGHER VALVE IS NOT BACKCHECK, IT'S A LOW PRESSURE CONTROL VALVE WITH 1 1/2 PSI. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE HORIZON PUMP IV SET PUMP IV SET FPA B BRAUN MEDICAL INC 352520 0060967404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention