BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET

    MDR report key: 5647115 · Received May 11, 2016

    Report

    Report Number
    2025816-2016-00039
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 10, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL RECEIPT INSPECTION: 5/5/2016 - RECEIVED ONE (1) USED B2032, 60" SMALLBORE EXT SET, LOT# UNKNOWN. NO MATING DEVICES WERE RETURNED. THE FEMALE LUER WAS CONFIRMED TO BE CRACKED. VISUAL INVESTIGATION: UNIT WAS VISUALLY EXAMINED AND THE FEMALE LUER WING AND TUBING POCKET WAS OBSERVED TO BE BROKEN/CRACKED. SUMMARY: THE REPORTED COMPLAINT OF "CRACK AT HUB" WAS CONFIRMED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND THE FAILURE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE B2032, 60" SMALLBORE EXT SET, LOT# UNKNOWN. REPORT STATES, "NEEDED TO INCREASE INSULIN INFUSION, PATIENT'S BLOOD SUGAR NOT RESPONDING. INVESTIGATED TUBING AND NOTICED CRACK AT HUB WHERE SYRINGE ATTACHES. PUMP NOTED TO BE WET." NO SERIOUS PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301133 EXT SET EXT SET FPA ICU MEDICAL, INC. B2032 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1