BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTARTION SET

    MDR report key: 4230474 · Received October 22, 2014

    Report

    Report Number
    9616066-2014-01049
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MANUFACTURER. 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

    THE CUSTOMER REPORTED TPN LEAKED FROM A CRACK IN THE ACCUSLIDE DURING AN INFUSION. TPN WAS STARTED AT 5PM AND THE LEAK WAS IDENTIFIED SOMETIME AFTER MIDNIGHT. THE SET WAS REPLACED AND THE INFUSION RESTARTED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670718 ALARIS SE ADMINISTARTION SET IV INFUSION SET FPA CAREFUSION CORPORATION 72003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SE PUMP: MODEL 7230A, SN UNKNOWN