BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 2891049 · Received November 14, 2012

    Report

    Report Number
    9616066-2012-00815
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PCA SET LEAKED AFTER THE INFUSION HAD BEEN RUNNING FOR A PERIOD OF TIME. THE TUBING DID NOT SEEM TO LEAK WHEN PRIMED, BUT LEAKED AFTER THE INFUSION STARTED. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO SPECIFIC EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE ADMINISTRATION SET FPA CAREFUSION CORP 30883 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PCA MODULE, SN UNK| ALARIS PC UNIT, SN UNK