BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL MEDICAL

    MDR report key: 2065704 · Received April 15, 2011

    Report

    Report Number
    MW5020302
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    PALL MEDICAL CORPORATION
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TPN FILTERS WERE FAULTY; NO FLUIDS WOULD COME THROUGH THE FILTER WHEN THE TPN WAS HUNG. AFTER ABOUT 5 TRIES ON THE PT, THE PT WAS SWITCHED TO DEXTROSE 10% UNTIL WE REALIZED THE NEXT DAY THAT IT WAS DUE TO FILTERS WITH A SPECIFIC LOT NUMBER. ONCE WE SWITCHED LOTS, THE TPN RAN FINE. PRODUCT: TOTAL NUTRIENT ADMIXTURE FILTER FROM (B)(4), LOT: 033711, EXP: 2015-07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL MEDICAL TOTAL NUTRIENT ADMIXTURE FILTER FPB PALL MEDICAL CORPORATION 033711

    Patients

    Seq Age Sex Outcome Treatment
    1