BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMUS

    MDR report key: 1192189 · Received October 7, 2008

    Report

    Report Number
    MW5008574
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MAXIMUS PRODUCT NO. AN IV TUBING WITH 3 TRU-SWAB CONNECTORS WAS INFUSING PT'S IV FLUID. ONE OF THE TRU-SWAB CONNECTORS SPONTANEOUSLY CAME OFF AND THE PT BLED OUT THE TUBING APPROX 50-75CC OF BLOOD. IV TUBING WAS CHANGED OUT. THE PT HAD NO UNTOWARD EFFECT. TOLD CATARACT SURGERY WITHOUT INCIDENT. VITAL SIGNS STABLE THROUGHOUT. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PT WAS HAVING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMUS NONE FPA 8350182

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR