BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET

    MDR report key: 6069364 · Received November 1, 2016

    Report

    Report Number
    3012307300-2016-00224
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE DEVICE AND RELATED DISPOSABLE TUBING WERE ONLY ABLE TO INFUSE APPROXIMATELY HALF OF EXPECTED BLOOD UNITS REQUIRED. A MASSIVE TRANSFUSION PROTOCOL WAS ACTIVATED ON A PATIENT EXPERIENCING A MASSIVE HEMORRHAGE. THE STAFF ATTEMPTED TO USE A 14 AND 16 GAUGE CANNULA WITHOUT SUCCESS. A CENTRAL LINE WAS ALSO UNSUCCESSFUL. ULTIMATELY THE HOSPITAL STAFF ENDED UP SQUEEZING THE BLOOD THROUGH TO THE PATIENT MANUALLY. A TOTAL OF 32 UNITS OF BLOOD HAD BEEN OPENED IN THE ATTEMPT TO MANUALLY INFUSE BLOOD INTO THE PATIENT. THE PROCEDURE LASTED 4 HOURS AND 10 MINUTES. THE PATIENT WAS DISCHARGED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING PROCEDURE AND WAS IN CRITICAL CONDITION. THE CLINICAL NURSE STATED "THAT THIS EVENT COULD BE ONE OF SEVERAL FACTORS LEADING TO THE PATIENT'S CURRENT CONDITION, HOWEVER, IT IS HARD TO CONCLUDE THAT THE DEVICE WAS RESPONSIBLE." SEE MFR: 3012307300-2016-00223.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721276 LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DEVICE, WARMING. BLOOD AND PLASMA KZL SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R