BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3983196 · Received June 27, 2014

    Report

    Report Number
    9616066-2014-00632
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 06/27/2014. (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    RADIOACTIVE ISOTOPE WAS INJECTED INTO THE IV TUBING; UPON SYRINGE DISCONNECTION, THE RADIOACTIVE ISOTOPE MATERIAL WAS LEAKING OUT OF THE IV SET. THE SOLUTION CAME INTO CONTACT WITH THE PT'S HAND. THERE WAS NO PT INJURY. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377249 ALARIS PUMP MODULE ADMIN SET IV INFUSION SET FPA CAREFUSION CORP 2426-0007 14045239

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYRINGE, MFR/MODEL/LOT UNK