BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 4898989 · Received July 1, 2015

    Report

    Report Number
    MW5043697
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 1, 2015
    Manufacturer
    KIMBERLY CLARK
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE SET UP A 5-FU INFUSION USING THE HOMEPUMP C- SERIES ELASTOMERIC PUMP PRODUCED BY I-FLOW. THE INFUSION BEGAN ON (B)(6) 2015 AT 2100 HOURS AND RAN DRY AT (B)(6) 2015 AT 0400. THE TOTAL INFUSION TIME IS SUPPOSED TO BE 46 HOURS AND THE INFUSION RAN ABOUT 31-32 HOURS. THIS IS THE 3RD INSTANCE OF THIS OCCURRING. WE PERFORMED OUR OWN INTERNAL AUDIT UTILIZING JUST SALINE AND THE TOTAL INFUSION TIME WAS ABOUT 41 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426598 HOMEPUMP C-SERIES HOMEPUMP C-SERIES MEB KIMBERLY CLARK C-SERIES 0201617874

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR