BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX, EVA CONTAINER, 3-LITER CAPACITY

    MDR report key: 2237985 · Received September 1, 2011

    Report

    Report Number
    MW5022095
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BAXA CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A RECURRING PROBLEM WITH BAXA CORPORATION EMPTY, 3-LITER, EXACTA-MIX EVA CONTAINER, THEIR REORDER NUMBER (B)(4). WE USE THIS CONTAINER TO DELIVER CITRATE SOLUTION FOR OUR PTS ON CVVH. WHEN THE ADMINISTRATION SET PORT (THE MIDDLE PORT) IS SPIKED, THE DIAPHRAGM IS SO VERY RESISTANT TO PENETRATION THAT IT CAUSES THE SPIKING NEEDLE TO CURL-BACK ON ITSELF ON OCCASION WITH BUT A SINGLE SPIKING, AND MORE OFTEN WHEN MULTIPLE BAGS ARE SPIKED. THESE CVVH BAGS ARE CHANGED EVERY 2-3 HOURS AND THE ADMINISTRATION SET, COMPLETE WITH SPIKE, IS GOOD FOR 72 HOURS. NURSES HAVE TO FREQUENTLY REPLACE THE SPIKE BEFORE THE SET HAS TO BE REPLACED. THE CURLBACK INCREASES FLOW RESISTANCE AND CAUSES THE PUMP TO SHUT DOWN. WHEN THE PUMP SHUTS DOWN, THE CVVH FILTER HAS TO BE REPLACED AT A COST OF SEVERAL HUNDRED DOLLARS. NURSES FIND IT REQUIRES EXTRAORDINARY FORCE TO SPIKE THIS PARTICULAR BAXA CONTAINER. THE SAME SPIKE, WHEN USED WITH OTHER CONTAINERS, HAS NOT BEEN ASSOCIATED WITH THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX, EVA CONTAINER, 3-LITER CAPACITY EVA CONTAINER KPE BAXA CORP. NOT LIMITED TO 10029
    2 ACCESSORY SPIKE ACCESSORY SPIKE LHI GAMBRO DASCO HOSPITAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other