BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5040716

    MDR report key: 4516363 · Received February 9, 2015

    Report

    Report Number
    MW5040716
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 9, 2015
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCUFLO (B)(4) LOT#100925 USED TO ADMINISTER A DOSE OF 5-FLUOROURACIL OVER 23 HOURS. THE DEVICE IS AN ELASTOMERIC INFUSION DEVICE WITH 4MG/HR RATE AND 120ML VOLUME. THE DEVICE WAS PLACED ON THE PT AT 1300 (B)(6) 2015 TO ADMINISTER THE DOSE OVER THE 23 HOURS. THE PT CALLED THE INFUSION CENTER ON (B)(6) 2015 STATING THAT THE DEVICE WAS EMPTY AT 0134 ON (B)(6) 2015. THE INFUSION SHOULD HAVE BEEN RUNNING UNTIL APPROX 1200 ON (B)(6) 2015. THE ENTIRE 23 HOUR INFUSION WAS INFUSED OVER APPROX 12 HOURS.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR