BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET

    MDR report key: 4912726 · Received July 10, 2015

    Report

    Report Number
    2183502-2015-00503
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 9, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OBSERVED THE 3 LUMEN TUBE TO APPEAR BENT AT THE SECTION OF THE UNION WITH THE STRAIN RELIEF. FUNCTIONAL TESTING WAS PERFORMED TO SIMULATE USE BY CONNECTING THE SET TO A FLUID WARMING MACHINE H-1200 AND IRRIGATING WATER. ONCE THE WARM WATER STARTED TO FLOW THROUGH THE UNIT THE TRIPLE LUMEN TUBE STARTED TO KINK AND ALARM ON THE AIR DETECTOR/CLAMP CONTROL PANEL SOUNDED AS WATER DID NOT FLOW THROUGH THE FILTER. THE TUBE WAS THEN CUT IN ORDER TO OBSERVE FURTHER AND IT WAS DISCOVERED THAT ALIGNMENT OF THE TUBE AND MANIFOLD RIBS WAS INCORRECT. MANUFACTURING PROCESS WAS REVIEWED AND AN AUDIT OF PRODUCTION FLOOR CONDUCTED BY MANUFACTURING ENGINEER AND CONFIRMED THAT ALL PROCEDURES ARE PERFORMED AS REQUIRED. IN ATTEMPT TO REPRODUCE THE REPORTED FAILURE MODE, TWO SAMPLES WERE TESTED ON THE H-1200 WITH ONE HAVING TRIPLE LUMEN TUBE ALIGNED WITH THE MANIFOLD RIBS CORRECTLY AND THE SECOND SAMPLE MISALIGNED. THE TRIPLE LUMEN THAT WAS ALIGNED CORRECTLY DID NOT KINK DURING IRRIGATION OF WATER. IN THE TRIPLE LUMEN TUBE THAT HAD MISALIGNMENT A KINK WAS OBSERVED, SIMILAR TO THE COMPLAINT SAMPLE. MOST PROBABLY ROOT CAUSE IS THAT THE MANIFOLD AND TRIPLE LUMEN TUBE WERE MISALIGNED DUE TO A BAD COILED TUBE THAT CAUSED THE TUBE TO TWIST AFTER ASSEMBLY. A RE-TRAINING ON PROCEDURE AND AWARENESS OF THIS EVENT WAS PERFORMED BY PRODUCTION SUPERVISOR.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    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 PT IN THE OPERATING ROOM, WHEN THE DISPOSABLE WAS REPORTEDLY KINKING RESULTING IN A LOSS OF FLOW RATE. THE SET WAS CONTINUED FOR USE SUCCESSFULLY WITH APPLICATION OF A SPLINT ACROSS THE KINK. NO ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448912 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET KZL SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK