BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3820792 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00431
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 17, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SECONDARY OF MAGNESIUM BACK FLOWED INTO THE PRIMARY BAG. THE IV SET WAS REPLACED AND THE INFUSION WAS RESTARTED WITHOUT INCIDENT. THERE WAS NO REPORT OF PT OR MED INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259557 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORP 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING: MFR/MODEL/LOT UNK