BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD

    MDR report key: 1828546 · Received September 1, 2010

    Report

    Report Number
    MW5017309
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVES TPN FOR 12 HOURS DAILY VIA AMBULATORY PUMP. ON (B)(6)2010, PT WAS SENT A SHIPMENT OF 6 BAGS, ALL OF WHICH WERE FREE OF AIR AS WELL AS FITTED WITH A TUBING WHICH WAS PRIMED AND READY FOR INFUSION. ON (B)(6)2010, HOME HEALTH NURSE WAS GETTING READY TO START TO INFUSE A BAG AND NOTICED THAT THE TUBING WAS ENTIRELY FILLED WITH AIR. IT TOOK MUCH TIME AND MANY MANIPULATIONS FOR THE NURSE TO GET THE TUBING TO PRIME AGAIN AND GET THE FLUID PAST THE LOCATION OF THE FILTER. DATES OF USE: (B)(6)2010-(B)(6)2010. DIAGNOSIS OR REASON FOR USE: ULCERATIVE COLITIS; INTESTINAL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD BODYGUARD ADMINISTRATION SET WITH 1.2 MICRON FILTER FPA CME AMERICA, LLC 120-112XSF 13891-10

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability