BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA TUBING

    MDR report key: 4822112 · Received June 5, 2015

    Report

    Report Number
    9616066-2015-00749
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    January 23, 2015
    Report Date
    June 1, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A BROKEN MALE LUER LOCK WAS CONFIRMED. VISUAL INSPECTION OF THE REST OF THE SET NOTED NO HOLES OR TEARS ON THE TUBING AND NO CRACKS, BREAKS, BRITTLE, STRESS MARKS OR CRAZING ON ANY OF THE OTHER COMPONENTS. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE OBVIOUS DAMAGE. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    PER CUSTOMER MAUDE REPORT, ¿RN WAS DISCONNECTING IV TUBING TO CONNECT ANOTHER SET OF TUBING AND THE ORIGINAL TUBING BROKE OFF FROM THE HUB.¿ PER NEW INFORMATION RECEIVED ON (B)(4) 2015, CUSTOMER REPORTS HYDROMORPHONE WAS INFUSING AND NURSE WAS SWITCHING TO INVANZ. CUSTOMER STATES THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364281 ALARIS PCA TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10800175

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR