BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SET

    MDR report key: 5753695 · Received June 27, 2016

    Report

    Report Number
    9616066-2016-00827
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 31, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF LEAKING WAS CONFIRMED. THE LEAKS ORIGINATED FROM MULTIPLE CRACKS FOUND ON THE FEMALE LUER WALL. VISUAL INSPECTION CONFIRMED NO EVIDENCE OF TOOL MARKS OR OVER TORQUE. THE CAUSE OF THE CRACKS WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: MEDLINE SYRINGE SWABFLUSH (ZR FLUSH SYRINGE W/INTEGRATED SWABCAP) MODEL E0103-01, LOT # 3127060, EXP 01/01/2018; THERAPY DATE 05/04/2016. 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

    RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA, WHICH STATES "A NURSE STATED SHE HAD OBSERVED AT LEAST 3 TIMES PCA TUBING LEAKING AT A PORT WITH A FLUSH SYRINGE CONNECTED TO IT. IT IS UNKNOWN IF THE LEAK IS FROM A FAULTY FLUSH SYRINGE OR TUBING PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405300 ALARIS PCA MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10800173 16016918

    Patients

    Seq Age Sex Outcome Treatment
    1