BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 6030537 · Received October 14, 2016

    Report

    Report Number
    9616066-2016-01401
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 23, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED AND NO ANOMALIES OR DAMAGE WERE OBSERVED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN THE LIQUID FLOWING NORMALLY WITH NO LEAKS OBSERVED. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BAXTER 250ML BAG OF 0.9% NACL INJECTION NDC (B)(4), LOT Y203588, EXP DEC 2017; BAXTER 250ML BAG OF 0.9% NACL INJECTION NDC (B)(4), LOT Y207357, EXP FEB 2018, THERAPY DATE UNK. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK ON THE SECONDARY TUBING WHILE INFUSING GEMCITABINE HCL 1620MG AT 585.212ML/HR OVER 30 MINUTES; SPECIFIC LOCATION OF THE LEAK WAS NOT IDENTIFIED. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LEAK ON THE SECONDARY TUBING AT THE LOCATION WHERE THE IV TUBING AND THE FIRST CONNECTION ARE BONDED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681319 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 10013364T

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 2426-0007, THERAPY DATE UNK