BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD INFUSION PUMP

    MDR report key: 2010876 · Received February 16, 2011

    Report

    Report Number
    2010876
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    August 3, 2010
    Report Date
    February 16, 2011
    Manufacturer
    MEDRAD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PUMP IS DESIGNED TO ALARM IF AIR GETS INTO PUMP TUBING AND STOPS INFUSION BEFORE AIR GETS PAST INFUSION PUMP. PUMP DIDN'T ALARM AND AIR WENT PAST PUMP. BIOMED CALLED MEDRAD (PUMP MANUFACTURER). SERVICE TECHNICIAN CAME IN TO REPLACE PUMP IN QUESTION WITH NEW PUMP AND VERIFIED PROPER OPERATION AND PLACED IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD INFUSION PUMP INFUSION PUMP FRN MEDRAD * 8205-9

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR