BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 20391510 · Received October 7, 2024

    Report

    Report Number
    1018233-2024-06306
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS A CONFIRMED USER RELATED, NOT ATTRIBUTED DEVICE MALFUNCTION. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS INADEQUATE MAINTENANCE OF THE DEVICE. THE DEVICE WAS EVALUATED UPON RECEIPT. LEVEL SENSOR NOT DETECTING WATER LEVEL DUE TO DIRTY WATER. LEVEL SENSOR WAS CLEANED. CTU CALIBRATION. DEVICE PASSED ALL TESTING AFTER REPAIR. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE MANUFACTURING RELATED. THE INSTRUCTIONS-FOR-USE UNDER BAW2800548 REV 1 AND ADDENDUM BAW2800424 REV 1 WERE REVIEWED AND FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. PER BAW2800548 REV 1: "CLEANING AND MAINTENANCE ROUTINE CLEANING AND PREVENTIVE MAINTENANCE SHOULD BE PERFORMED ON THE ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM CONTROL MODULE EVERY 6 MONTHS AT A MINIMUM. THIS CONSISTS OF CLEANING THE EXTERNAL SURFACES, ACCESSORIES AND CHILLER CONDENSER, INSPECTING THE DEVICE, AND REPLENISHING THE INTERNAL CLEANING SOLUTION THAT SUPPRESSES MICROORGANISM GROWTH IN THE WATER RESERVOIR AND HYDRAULIC CIRCUIT. SEE THE ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM SERVICE MANUAL FOR ADDITIONAL INFORMATION." AND "TO REPLENISH THE INTERNAL CLEANING SOLUTION: 1) DRAIN THE RESERVOIR. ¿ TURN CONTROL MODULE POWER OFF. ¿ ATTACH THE DRAIN LINE TO THE TWO DRAIN PORTS ON THE BACK OF THE CONTROL MODULE. PLACE THE END OF THE DRAIN LINE INTO A CONTAINER. THE WATER WILL PASSIVELY DRAIN INTO THE CONTAINER. 2) REFILL THE RESERVOIR ¿ FROM THE HYPOTHERMIA THERAPY SCREEN OR THE NORMOTHERMIA THERAPY SCREEN, PRESS THE FILL RESERVOIR BUTTON. ¿ THE FILL RESERVOIR SCREEN WILL APPEAR. FOLLOW THE DIRECTIONS ON THE SCREEN. ¿ ADD ONE VIAL OF ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM CLEANING SOLUTION TO THE FIRST BOTTLE OF STERILE WATER. ¿ THE FILLING PROCESS WILL AUTOMATICALLY STOP WHEN THE RESERVOIR IS FULL. CONTINUE TO REPLACE THE BOTTLES OF STERILE WATER UNTIL THE FILLING PROCESS STOPS. ¿ WHEN THE FILL RESERVOIR PROCESS IS COMPLETE, THE SCREEN WILL CLOSE." THE INITIAL REPORTER CUSTOMER NAME THAT IS AVAILABLE IS HOST. GENERAL JUAN RAMON JIMENEZ SERVICE U.C.I. 3RD FLOOR A/A DR. THE REPORTED PRODUCT NUMBER IS SOLD OUS. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED TO REGULATE THE TEMPERATURE. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2024, IT WAS REPORTED THAT THE LEVEL SENSOR NOT DETECTING WATER LEVEL DUE TO DIRTY WATER. FILL TUBE NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541320 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other