BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4092414 · Received September 5, 2014

    Report

    Report Number
    9616066-2014-00934
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOOD WAS LEAKING FROM THE IV SET DURING D5LR INFUSION. THERE WAS APPROXIMATELY 1 FOOT OF BLOOD BACKED UP IN THE PT'S IV SET AND THERE WAS BLOOD FOUND ON THE FLOOR AND THE PT'S BED. THIS WAS FOUND BY THE CLINICAL STAFF DURING PT ROUNDS. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545997 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK