BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS INFUSION CONTROLLER

    MDR report key: 1843520 · Received September 15, 2010

    Report

    Report Number
    1843520
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO SET ANGIOMAX INFUSION ON IV PUMP, WHILE ATTACHING 2ND MODULE TO PUMP IT ALARMED "DISCONNECTED." I RESET AND ATTEMPTED TO START ANGIOMAX INFUSION AND PUMP ALARMED "BLOCKAGE IN PUMP." AFTER THIS THE PUMP WOULD NOT WORK AND NEW PUMP AND MODULE HAD TO BE OBTAINED. THIS RESULTED IN THE PT NOT GETTING ANTI-THROMBOLYTIC MEDICATION IN A TIMELY MANNER DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION CONTROLLER INFUSION PUMP FRN CAREFUSION * *
    2 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION * *
    3 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR