BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALRIS PCA MODULE ADMINISTRATION SET

    MDR report key: 3133823 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00303
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A CRACK IN THE FEMALE LUER OF THE Y-CONNECTOR RESULTING IN A LEAK COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CRACK WAS FOUND ON THE FEMALE LUER OF THE Y-CONNECTOR THAT CAUSED SOME LEAKAGE DURING AN INFUSION. THEY ARE NOT SURE IF THE LEAKAGE WAS THE PCA MEDICATION OR MAINLINE FLUID. NO PT HARM. THE SET WAS DISCARDED. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190917 ALRIS PCA MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 30873 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PCA MODULE: S/N UNK| ALARIS PUMP MODULE: S/N UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT: UNK| ALARIS PC UNIT: S/N UNK