BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2576431 · Received April 25, 2012

    Report

    Report Number
    2576431
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 25, 2012
    Manufacturer
    BAXTER
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) EXCHANGE STARTED ON PATIENT. NURSE NOTED A LARGE AMOUNT OF EFFLUENT ON THE FLOOR. DRAIN BAG INSPECTED AND FOUND A SMALL TEAR/PUNTURE IN THE BAG. THOUGHT TO BE A DEFECTIVE BAG. HOLE IN DRAIN BAG WAS NOT NOTICED UNTIL EFFLUENT FILLED THE BAG AND STARTED DRAINING OUT. PATIENT TRANSFER SET IMMEDIATELY CLAMPED. A NEW CAPD SYSTEM WAS CONNECTED TO THE PATIENT, AND DIALYSIS WAS RESUMED WITH START OF DRAIN. THE DRAIN BAG COMES IN A KIT WITH THE DIALYSIS SOLUTION (EFFLUENT). BAXTER MAKES THE EFFLUENT (DIANEAL LOW CALCIUM PERITONEAL DIALYSIS SOLUTION, NDC 0941-0430-52, LOT #5B9776, EXP 02/2013). I DO NOT KNOW WHO MANUFACTURES THE DRAIN BAG ITSELF, BUT IT COMES PACKAGED WITH THE EFFLUENT SOLUTION FROM BAXTER. THE BAG AND PACKAGING WERE DISCARDED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DRAIN BAG, DIALYSIS FKX BAXTER NDC 0941-0430-52 5B9776

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR