BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTICGEL COOLING KIT MEDIUM

    MDR report key: 21585863 · Received March 12, 2025

    Report

    Report Number
    1018233-2025-01634
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 24, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080081
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION AND FOUND ADEQUATE. CORRECTIONS: D, H UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 THEY WERE INITIATING THERAPY USING AN ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 6778.8 AND SYSTEM HOURS WERE 7355. ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT PADS. ENABLED MANUAL MODE. NO VISIBLE DAMAGE TO FLUID DELIVERY LINE (FDL) AND IT WAS FULLY SEATED. IN MANUAL WITHOUT PADS FLOW RATE (FR) WAS 1.6LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.7LPM, INLET PRESSURE (IP) WAS -7.3PSI, 34 PERCENTAGE. CONNECTED LEFT CHEST PAD. 0LPM, -0.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. VALUES DID NOT IMPROVE WHEN MOVING TO ANOTHER VALVE SET. FLOW RATE (FR) REMAINED 0LPM AND INLET PRESSURE (IP) WAS -0PSI WHEN CONNECTING RIGHT PADS. SUGGESTED REPLACING PADS, LOT NGJX2427. WALKED THROUGH DISABLING MANUAL CONTROL. ASKED NURSE TO PUT PADS BEHIND NURSING STATION IF THEY WANT THEM RETURNED TO QUALITY FOR INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE INITIATING THERAPY USING AN ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 6778.8 AND SYSTEM HOURS WERE 7355. ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT PADS. ENABLED MANUAL MODE. NO VISIBLE DAMAGE TO FLUID DELIVERY LINE (FDL) AND IT WAS FULLY SEATED. IN MANUAL WITHOUT PADS FLOW RATE (FR) WAS 1.6LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.7LPM, INLET PRESSURE (IP) WAS -7.3PSI, 34 PERCENTAGE. CONNECTED LEFT CHEST PAD. 0LPM, -0.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. VALUES DID NOT IMPROVE WHEN MOVING TO ANOTHER VALVE SET. FLOW RATE (FR) REMAINED 0LPM AND INLET PRESSURE (IP) WAS -0PSI WHEN CONNECTING RIGHT PADS. SUGGESTED REPLACING PADS, LOT NGJX2427. WALKED THROUGH DISABLING MANUAL CONTROL. ASKED NURSE TO PUT PADS BEHIND NURSING STATION IF THEY WANT THEM RETURNED TO QUALITY FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147875 ARCTICGEL COOLING KIT MEDIUM ARCTICGEL COOLING KIT MEDIUM DWJ MEDIVANCE, INC. ¿ 1725056 NGJX2427 00801741080081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other