BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMSTAR INFUSION PUMP

    MDR report key: 2875408 · Received December 7, 2012

    Report

    Report Number
    MW5028082
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 7, 2012
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPEATED "AIR-IN-LINE" ALARMS ON GEMSTAR PUMP. CHAMPAGNE BUBBLES NOTED IN 1.2 MICRON GEMSTAR TUBING. UNABLE TO PRIME AIR OUT OF LINE. PAGED ON CALL IV RN WHO INSTRUCTED FOR PATIENT TO DISCARD CURRENT ANTIBIOTIC BAG AND CHANGE TO NEW ONE. NEW BAG OK X 3 HOURS THEN AIR IN LINE ALARM. PATIENT REPORTED SEVERAL AIR IN LINE ALARMS DAILY SINCE START OF CARE ON (B)(6) 2012. HOMECARE PATIENT. SUBMITTED DETAILED REPORT/COMPLAINT TO HOSPIRA ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention