BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9" BIFUSE EXT. SET

    MDR report key: 5375945 · Received January 19, 2016

    Report

    Report Number
    2025816-2016-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    December 23, 2015
    Report Date
    December 19, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT NUMBER 13-607-HE SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASE IN (B)(6) 2012 WITH NO ANOMALIES CITED IN PRODUCTION. A PICTURE WAS SUPPLIED WITH THE COMPLAINT BUT WE ARE UNABLE TO CONCLUDE A ROOT CAUSE BASED ON THE PHOTOGRAPH. NOT RETURNED FOR EVALUATION

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 12518-01, 9" BIFUSE EXT. SET, LOT# 13-607-HE (MFGD. 01/2012). REPORT STATES, "THE CONNECTOR CAME OFF OF THE LINE WHILE ON THE PATIENT AND IT WAS ATTACHED TO A CENTRAL LINE." THERE WAS A DELAY IN THERAPY AND A POSSIBILITY OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34188 9" BIFUSE EXT. SET 9" BIFUSE EXT. SET FPA ICU MEDICAL, INC. 12518-01 13-607-HE

    Patients

    Seq Age Sex Outcome Treatment
    1