BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SECONDARY ADMINISTRATION SET

    MDR report key: 6697698 · Received July 10, 2017

    Report

    Report Number
    9616066-2017-00987
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 19, 2017
    Report Date
    June 21, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML B.BRAUN BAG NDC 0264-7800-10, LOT NUMBER J7D070, EXP 10/2019, PARALATIN SODIUM CHLORIDE 0.9%. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A TUBING LEAK WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED NO OBVIOUS DAMAGE ON ANY COMPONENT OF THE SECONDARY SET. FUNCTIONAL AND PRESSURE TESTING ON THE RECEIVED SET OBSERVED LEAKING AT THE ENGAGEMENT BETWEEN THE TEXIUM LUER AND VARIOUS LAB MATING COMPONENTS. THE PROBABLE CAUSE OF THE OBSERVED LEAK FROM THE TEXIUM LUER WAS DUE TO A LEAK PATH AT THE BASE OF THE TEXIUM VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 542 ML BAG OF CARBOPLATIN WAS INFUSING WHEN THE NURSE NOTICED MOISTURE AROUND THE PUMP AND ON THE FLOOR. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477912 ALARIS® SECONDARY ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 70001B-07T

    Patients

    Seq Age Sex Outcome Treatment
    1 8100, 8015, THERAPY DATE (B)(6) 2017