BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 2140715 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00329
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE REPORTED LEAK. THE REPORTER INDICATED THAT THE DEVICE WAS NOT SAVED. ROOT CAUSE OF THE REPORTED LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    RECEIVED A REPORT OF PCA SET "LEAKING AT THE HUB". SET WAS NOT SAVED. THERE WAS NO PATIENT HARM. REPORTER STATED THAT THERE IS A NEW ANESTHESIA GROUP IN THE FACILITY WHICH USES THESE SETS AND HE DOESN'T KNOW IF THAT MAY BE A FACTOR. CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 30893 10106272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: S/N UNK| ALARIS PCA MODULE: S/N UNK