BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1833469 · Received August 24, 2010

    Report

    Report Number
    1833469
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    RN SET PUMP TO INFUSE PRE-MEDICATION OVER 20 MINUTES PER LABEL. PRE-MEDICATION INFUSED OVER 20 MINUTES BUT RN NOTED AIR IN LINE IN THE CASSETTE CHAMBER AT END OF INFUSION. RN THEN SET PUMP TO INFUSE AVASTIN OVER 30 MINUTES PER LABEL. PUMP ALARMED "AIR IN LINE" AFTER 22 MINUTES AND ALL AVASTIN HAD ALREADY INFUSED. RN & PHARMACIST REVIEWED PUMP PROGRAMMING AND VERIFIED IT HAD BEEN SET CORRECTLY. PUMP TAKE OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ IV INFUSION PUMP FRN HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR