BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 2216030 · Received August 12, 2011

    Report

    Report Number
    MW5021766
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER 250ML 0.9% SODIUM CHLORIDE INJ, PRODUCT # 6E1322, LOT#C831677. PHASEAL INFUSION ADAPTER C100, LOT 11030936, WITH BAXTER PACLITAXEL SET 2C8858. ADMIXTURE WITH PACLITAXEL, 6MG/ML, APP PHARMACEUTICAL. TWICE IN 2 WEEKS, AT PT BEDSIDE, THE SPIKE SET FELL OUT OF THE BAG PORT. ONE EPISODE RESULTED IN EXPOSURE TO THE ADMINISTRATION NURSE, WITH THE CHEMOTHERAPY SOLUTION SPILLING OUT ON HER CLOTHING AND SKIN. A THIRD EPISODE HAPPENED WITH A PHARMACY TECHNICIAN PREPARING CHEMOTHERAPY IN THE BIOLOGICAL SAFETY CABINET, AND HAD JUST SPIKED THE TUBING SET -WITHOUT THE PHASEAL DEVICE- AND WAS PREPARING TO PRIME THE SET WITH BASE SOLUTION. THE TUBING SET SPIKE SLIPPED OUT OF THE BAG PORT. NO CHEMOTHERAPY EXPOSURE IN THIS INSTANCE, AS IT WAS BASE SOLUTION ONLY. I SUSPECT A DEFECT OR ISSUE WITH THE 250ML BAG SPIKE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER 250ML 0.9% SODIUM CHLORIDE KPE BAXTER HEALTHCARE CORP. 6E1322 C831677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PHASEAL INFUSION ADAPTOR C100, LOT 11030936| PACLITAXEL 6MG/ML HPP PHARMACEUTICAL| BAXTER PACLITAXEL SET, 2C8898