BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO DAY INFUSOR

    MDR report key: 2186845 · Received July 27, 2011

    Report

    Report Number
    MW5021550
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE, SA
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MEDICATION RESERVOIR IN BAXTER 48HR INFUSOR BURST AND MEDICATION WAS RELEASED IN TO THE INFUSOR AND A SMALL AMOUNT OUTSIDE THE INFUSOR. TWO DAY INFUSOR WAS PLACED ON THE PT UPON COMPLETION OF HIS CHEMOTHERAPY INFUSION AROUND 2 PM ON (B)(6) 2011. PT RETURNED TO INFUSION THERAPY THE NEXT DAY WITH THE INFUSOR WHICH HAD BUSTED. REASON FOR USE: COLON CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWO DAY INFUSOR 2 DAY INFUSOR MEB BAXTER HEALTHCARE, SA C1075 10N027

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability