BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4214084 · Received August 14, 2014

    Report

    Report Number
    9616066-2014-00837
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 1, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SECONDARY IV INFUSION BACK FLOWED INTO PRIMARY IV BAG. THEY WERE UNABLE TO DETERMINE IF PT RECEIVED ANY OF THE DRUG IN SECONDARY BAG. INFUSION STOPPED AND CONNECTED TO ANOTHER PUMP. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487122 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP 2426-0007 14055449

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PUMP MODULE: SN: UNK| SECONDARY SET: MODEL: 72215N, LOT: UNK| ALARIS PC UNIT: SN: UNK