BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET

    MDR report key: 5008436 · Received August 11, 2015

    Report

    Report Number
    2183502-2015-00575
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.,
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVEN PHOTOGRAPHS OF THE COMPLAINT PRODUCT WERE PROVIDED BY CUSTOMER. THESE PHOTOGRAPHS SHOWED THE LEVEL 1 FLUID WARMING SET WITH A DETACHED LUER CONNECTOR AND AN UNATTACHED STOPCOCK (UNKNOWN MANUFACTURER). FIVE SAMPLES WERE RETURNED FOR EVALUATION: ONE OF THESE DEVICES WAS IN USED CONDITION AND RETAINED THE SWIVEL RETURN CONNECTOR BUT WAS MISSING THE LUER CONNECTOR. EXAMINATION OF THE USED SAMPLE SHOWED THE MEASURED DIMENSIONS OF THE SWIVEL RETURN CONNECTOR WERE WITHIN SPECIFICATIONS. BECAUSE THE DETACHED LUER CONNECTOR WAS NOT RETURNED FOR THIS SAMPLE, NO FUNCTIONAL TESTING COULD BE PERFORMED WITH THIS SAMPLE. THE MANUFACTURING FACILITY PERFORMED AN EXAMINATION OF THE UNUSED SAMPLES. THE RETURNED UNUSED SAMPLES WERE ALL FOUND TO MEET WITH SPECIFICATIONS (TUBING ASSEMBLIES, SWIVEL RETURN CONNECTORS AND LUER CONNECTORS WERE ALL ASSEMBLED AS PER SPECIFICATIONS). BECAUSE ONLY A PORTION OF THE USED COMPLAINT DEVICE WAS RETURNED; THE ROOT CAUSE COULD NOT BE DEFINITELY ESTABLISHED. THE MANUFACTURING FACILITY PERFORMED AN AUDIT OF THE MANUFACTURING PROCESS FOR THIS DEVICE; THIS REVIEW SHOWED NO PRODUCTS WITH SIMILAR LUER CONNECTOR DETACHMENT OR PROBLEMS WITH THE ASSEMBLY PROCESS. THIS REVIEW DETERMINED THAT THE ASSEMBLY WAS BEING PERFORMED AS PER MANUFACTURING PROCEDURE AND THE PRODUCTS PRODUCED WERE MEETING WITH IN-PROCESS INSPECTION CRITERIA. THE INSPECTION CRITERIA INCLUDE: VISUAL INSPECTION FOR VOIDS, DENTS OR CRACKS; SEPARATION FORCE TESTING AND TORQUE VERIFICATION TESTING. THE INVESTIGATION COULD NOT CONFIRM THE REPORTED ISSUE OCCURRED DUE TO AN INTRINSIC DEVICE PROBLEM.

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    ACCORDING TO REPORTER, THE DEVICE WAS BEING PREPARED PRIOR TO USE WITH PATIENT. THE PATIENT WAS ALREADY IN HYPOVOLEMIC SHOCK. WHEN THE DEVICE LUER WAS ATTACHED TO THE 3 WAY STOPCOCK (BRAND NAME NOT PROVIDED), THE FLUID WARMING SET LUER BECAME DETACHED FROM THE REST OF THE SET. ACCORDING TO REPORTER, THE PATIENT REQUIRED RESUSCITATION DURING THIS TIME WHEN AN ALTERNATE SET WAS PREPARED. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523625 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET KZL - BLOOD AND PLASMA WARMING DEVICE KZL SMITHS MEDICAL ASD, INC., NA 2788536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention