BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 2140717 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00327
    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). ALTHOUGH EXPECTED, THE DEVICE HAS NOT BEEN RECEIVED YET FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    RECEIVED A REPORT OF PCA SET "LEAKING AT THE HUB". LEAK WAS AT MALE END AND THERE ARE NO VISIBLE CRACKS. 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 PCA MODULE: S/N UNKNOWN| ALARIS PC UNIT: S/N UNKNOWN