BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAG

    MDR report key: 1562922 · Received December 2, 2009

    Report

    Report Number
    MW5014012
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 2, 2009
    Manufacturer
    GAMBRO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY TWO COMPARTMENT BAG SEPARATED BY A PEEL SEAL. (BGK 2/0) 5000 ML BAG. LOT # P9G304, EXP DATE: 01/2011. WHEN ATTEMPTING TO MIX THE PRODUCT CONTENTS, THE PEEL SEAL SPLIT OPEN, RESULTING IN THE PRODUCT CONTENTS POURING OUT OF THE BAGS. WE HAVE ALSO BEEN EXPERIENCING BAG LEAKAGE WITH THESE PRODUCTS. WE DO NOT HAVE THE LOT NUMBER OR EXP DATE FOR THOSE BAGS. CONCERN ABOUT PRODUCT CONTENT INTEGRITY/CONTAMINATION WITH THE LEAKING BAGS. DOSE OR AMOUNT: 3000 ML; FREQUENCY: PER HOUR; ROUTE: IV. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CONTINUOUS RENAL REPLACEMENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAG CVVH BAGS FII GAMBRO BGK 2/0 P9G304

    Patients

    Seq Age Sex Outcome Treatment
    1