BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD

    MDR report key: 1828512 · Received September 1, 2010

    Report

    Report Number
    MW5017308
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 24, 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 IS RECEIVING TPN OVER 12 HOURS DAILY. PHARMACY SHIPPED TO PT 7 BAGS ON (B)(6)2010. ALL BAGS WERE FREE OF AIR AND FITTED WITH TUBING, WHICH WAS PRIMED. ON (B)(6)2010, PT WAS READY TO INFUSE A BAG AND NOTICED THAT TUBING WAS ENTIRELY FULL OF AIR. PT CALLED PHARMACIST ON CALL WHO INSTRUCTED PT HOW TO RE-PRIME THE TUBING USING THE PUMP. AFTER A FEW ATTEMPTS - THERE SEEMED TO BE DIFFICULTY FOR THE FLUID TO BE ABLE TO PUSH PAST THE FILTER-, THE TUBING WAS FINALLY RE-PRIMED AND PT PROCEEDED WITH INFUSION. DATES OF USE: (B)(6)2010 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: MALNUTRITION.

    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 13892-10

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability