BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1® FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS

    MDR report key: 6077056 · Received November 3, 2016

    Report

    Report Number
    3012307300-2016-00241
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    September 17, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEVEL 1 FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SET WAS USED DURING RESUSCITATION WHEN THE BLOOD PRODUCT WAS SEVERELY DELAYED DURING A RAPID BLOOD TRANSFUSION. IT WAS UNKNOWN WHETHER A CENTRAL LINE OR A PERIPHERAL INTRAVASCULAR CATHETER WAS USED. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728233 LEVEL 1® FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS DEVICE, WARMING. BLOOD AND PLASMA KZL SMITHS MEDICAL ASD, INC. 3151180

    Patients

    Seq Age Sex Outcome Treatment
    1