BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SETS

    MDR report key: 6612941 · Received June 5, 2017

    Report

    Report Number
    9616066-2017-00861
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    May 6, 2017
    Report Date
    May 25, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    250ML BAXTER BAG NDC 0338-0049-02, LOT NUMBER Y223537, EXP JUL 18, 0.9% NACL, THERAPY DATE (B)(6) 2017. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    GTIN NUMBER FOR ITEM: (B)(4), LOT: 17015194 IS 10885403273940. THE CUSTOMER¿S REPORT THAT THE PCA TUBING BROKE AND LEAKED WAS CONFIRMED. VISUAL INSPECTION REVEALED THAT THE FEMALE LUER HAD A VERTICAL HAIR LINE CRACK THAT MEASURED 0.419 INCHES LONG. THE LUER WAS INSPECTED UNDER MAGNIFICATION AND NO STRESS MARKS WERE OBSERVED. FUNCTIONAL TESTING CONFIRMED A LEAK THROUGH THE CRACK. PRESSURE TESTING RESULTED IN NO LEAKING WHILE THE TUBING WAS MANIPULATED AT EACH ENGAGEMENT. THE CAUSE OF THE LEAK WAS IDENTIFIED AS A CRACKED FEMALE LUER. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PCA TUBING BROKE AT SITE WHERE KVO PORT MEETS AND LEAKED OVER THE BED AND FLOOR. THERE IS NO REPORT OF PATENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392421 ALARIS PCA MODULE SETS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 30873 17015194

    Patients

    Seq Age Sex Outcome Treatment
    1