BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS ADD TO INQUIRY ADD TO

    MDR report key: 5464685 · Received February 26, 2016

    Report

    Report Number
    2183502-2016-00300
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    October 7, 2015
    Report Date
    February 26, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL IN REGARDS TO INCIDENT PERTAINING TO THE HIGH FLOW FLUID WARMER IV SET STERILE. IT WAS REPORTED THAT THE SOLUTION FOR PRIMING WAS RINGERS LACTATE SOLUTION AND ALL LINES WERE PRIMED AND CLAMPED OFF DURING USE. ONCE THE FLUID BAG WAS EMPTY IT WAS CLAMPED. NOT ALL AIR WAS REMOVED FROM THE FLUID BAG, BUT THE BAG WAS NOT EMPTY WHEN THE AIR REACHED THE PATIENT; THE REST OF THE CONTENT OF THE SAME BAG IS ADMINISTERED "COLD" USING GRAVITY AFTER REMOVING THE AIR FROM THE LINE. IT WAS NOTED THAT THE GAS VENT FILTER WAS NOT REPLACED DURING THE PROCEDURE. THE ONLY IV TUBING THAT WAS ATTACHED TO THE PATIENT WAS THE DI-300 SET, AND IT WAS APPLIED TO THE LEFT ARM OF THE PATIENT. MEDICATIONS WERE APPLIED BY THE CENTRAL LINE. IT WAS ALSO DOCUMENTED THAT THE FLUID ADMINISTRATION WAS ADMINISTERED BY PRESSURE UNDER GRAVITY AT 300 MMHG. WHEN THE AIR IN THE LINE WAS NOTED, IT HAD BEEN IN USE FROM 14H40 START OR, TO 20H50 OR AFTER APPROXIMATELY 6 HOURS IN USE. THE HOSPITAL STATED THAT THE PATIENTS CURRENT CONDITION IS INCOMPLETE PARALYSIS THORACIC (TH2), PROBABLY NOT RELATED TO THE AIR. THE PATIENT WAS TRANSFERRED TO A REHABILITATION CLINIC AND THE EXPECTATION IS THAT THE SPINAL CORD INJURY IS PERMANENT. MFR# CLARIFICATION: NEW REGISTRATION NUMBER 3012307300 (B)(4) HAS BEEN RECEIVED, HOWEVER, THIS INITIAL MDR WAS FILED UNDER THE PRIOR REGISTRATION NUMBER 2183502 (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH FLOW FLUID WARMER IV SET STERILE WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE WAS RECEIVED FOR EVALUATION IN USED CONDITION, WITHOUT ITS ORIGINAL PACKAGING AND INSIDE A PLASTIC BAG. VISUAL INSPECTION FOUND NO DAMAGE IN COMPONENTS OR DELAMINATED SOLVENT BONDS, ALSO MEMBRANE FROM GAS VENT FILTER SHOWED NO DAMAGE OR BAD WELDING TO THE END CAP CONNECTOR. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS CONNECTED TO THE FLUID WARMING MACHINE H-1200 IN ORDER TO TRY TO CONFIRM THE FAILURE MODE. THE USED DEVICE WAS CONNECTED AND TESTED; THE DEVICE WAS NOT FUNCTIONAL SINCE THE DEVICE CANNOT BE PRIMED PROPERLY, IT WAS DETECTED THAT THE MEMBRANE DOES NOT LET THE AIR GO THROUGH IT CAUSING THAT THE LIQUID DOES NOT FILL THE FLUID LINE AND AN ALARM IN THE EQUIPMENT WAS ACTIVATED. THE FILTER GAS/VENT ASSEMBLY WAS CHANGED WITH A RECENTLY ASSEMBLED ONE IN PRODUCTION LINE; THE GAS VENT ASSEMBLY WORKED PROPERLY AND PRIMED THE FLUID LINE AS EXPECTED. INSTRUCTIONS FOR USER WERE REVIEWED AND THE FOLLOWING SECTION WAS FOUND REGARDING CHANGE OF THE GAS/VENT FILTER. REPLACE GAS VENT/FILTER ASSEMBLY EVERY THREE HOURS, OR WHEN THE FILTER BECOMES CLOGGED, OR WHEN AIR IS SLOWLY VENTED. FAILURE TO DO SO WILL RESULT IN A REDUCTION OF FLOW RATE. THIS MAY RESULT IN ADEQUATE PATIENT TREATMENT. THE COMPLAINT WAS CONFIRMED AND ROOT CAUSE COULD BE ASSOCIATED TO EITHER A DAMAGED DEVICE OR CLOGGING DUE TO THE LONGTIME USE OF LOSING ITS CAPABILITY TO VENT AIR BUBBLES FROM THE PATIENT LINE. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE ADMINISTRATION SET AND FLUID WARMER WERE IN USE WITH PATIENT FOR FLUID WARMING DURING SURGERY (PROCEDURE TYPE AND TOTAL TIME IN USE NOT REPORTED). ACCORDING TO REPORTER, AIR WAS DELIVERED TO PATIENT THROUGH THE ADMINISTRATION SET DURING THE OPERATION. ACCORDING TO REPORTER, FOLLOWING THE OPERATION THE PATIENT SUSTAINED PARALYSIS; THE REPORTER COULD NOT DEFINITELY CONFIRM THE CAUSE OF THE PARALYSIS. THE REPORTER PERFORMED AN INTERNAL INVESTIGATION OF THE EVENT STARTING (B)(6) 2015 AND REPORTED EVENT TO SMITHS MEDICAL ON (B)(6) 2016. ON (B)(6) 2016, A SMITHS MEDICAL FIELD SERVICE ENGINEER PERFORMED SERVICE CHECKS AND TESTING OF THE LEVEL 1 FAST FLOW FLUID WARMER (SERIAL NUMBER (B)(4)) AND HAS NOT CONFIRMED ANY DEVICE PROBLEMS. SMITHS MEDICAL HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE REQUESTED INFORMATION INCLUDES: DETAILS ON THE PREPARATION AND PRIMING OF THE ADMINISTRATION SET, CLAMPING PRACTICES, MANAGEMENT OF THE GAS VENT FILTER COMPONENT OF THE ADMINISTRATION SET, TIME IN USE WHEN THE EVENT WAS NOTED AND PATIENT OUTCOME INFORMATION (INCLUDING REGION OF BODY AFFECTED AND CURRENT PATIENT CONDITION). IF THIS INFORMATION IS RECEIVED FROM REPORTER, SMITHS MEDICAL WILL FILE A FOLLOW UP REPORT WITH THIS INFORMATION INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118906 LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS ADD TO INQUIRY ADD TO BLOOD AND PLASMA WARMING DEVICE KZL SMITHS MEDICAL ASD INC., NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R| S