BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMASOL BGK 2/0

    MDR report key: 6431317 · Received March 22, 2017

    Report

    Report Number
    MW5068627
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 22, 2017
    Manufacturer
    GAMBRO/BAXTER
    Product Code
    KPO
    UDI-DI
    2457110206
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRISMASOL BGK 2/0, MFG GAMBRO/BAXTER, LOT 766021; EXP 03/31/2018. THE PREVIOUS BAGS HAD A LABEL PLACED ONTO THE BACK OF THE BAG WHICH CONTAINED THE NDC AZTEC BARCODE, LOT # AND EXP. THERE IS A WHITE, LINEAR NDC BARCODE ON THE FRONT OF THE BAG AND THAT BARCODE STILL REMAINS. WE ARE A PEDIATRIC HOSPITAL. THE PRISMASOL IS USED FOR CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY). THE PRISMASOL HAS OTHER ELECTROLYTES ADDED BY THE PHARMACY BEFORE BEING DISPENSED TO THE PATIENT. WE USE DOSEEDGE (BAXTER) FOR OUR STERILE COMPOUNDING. THE WHITE, LINEAR BARCODE ON THE BAG DOES NOT SCAN IN DOSEEDGE. IT IS TOO LIGHT AND LONG FOR THE SCANNER. THE NEW BAGS HAVE THE LOT AND EXP PRINTED ONTO EITHER THE OVERWRAP OF THE BAG. IT IS DIFFICULT TO TELL. BUT WHEN THE OVERLAP IS REMOVED PRIOR TO COMPOUNDING, THE LOT # AND EXP ARE BLURRED AND ARE NOT LEGIBLE. SOME BAGS ARE SLIGHTLY LEGIBLE. ALSO IN THE DOSEEDGE SYSTEM, THIS CAN NOT BE DOCUMENTED WITH A PHOTOGRAPH IN THE SYSTEM. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208723 PRISMASOL BGK 2/0 DIALYSATE KPO GAMBRO/BAXTER 766021 2457110206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other