BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET

    MDR report key: 4913018 · Received July 8, 2015

    Report

    Report Number
    2183502-2015-00496
    Event Type
    Injury
    Date Received
    July 8, 2015
    Report Date
    July 7, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR. COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED EXPLAINING THAT THE LISTED DISPOSABLE WAS BEING USED WITH AN INFUSION DEVICE FOR RAPID DELIVERY ON A PAEDIATRIC PATIENT IN THE OPERATING ROOM, WHEN RESISTANCE WAS FELT ON THE SYRINGE WHEN PULLING FLUID THROUGH THE DEVICE. THE DISPOSABLE WAS REPORTEDLY KINKING RESULTING IN A LOW FLOW RATE. THE DEVICE HAD TO BE REMOVED AND UN-WARMED BLOOD HAD TO BE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441810 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET KLZ-BLOOD AND PLASMA WARMING DEVICE KZL SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R