BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

    MDR report key: 21849376 · Received April 16, 2025

    Report

    Report Number
    1018233-2025-02709
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    April 9, 2025
    Report Date
    October 22, 2025
    Manufacturer
    MEDIVANCE -1725056
    Product Code
    DWJ
    UDI-DI
    00801741132131
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE INITIAL REPORTER PHONE NUMBER THAT WAS PROVIDED IS (B)(6). THE INITIAL REPORTER FAX NUMBER THAT WAS PROVIDED IS (B)(6). THE COMPLETE CUSTOMER'S NAME IS GYNECOLOGICAL AND OBSTETRICS CLINICAL HOSPITAL OF THE (B)(6) MEDICAL UNIVERSITY. 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 INITIAL REPORTER'S PHONE NUMBER: (B)(6). THE INITIAL REPORTER'S FAX NUMBER: (B)(6). THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS AN AIR LEAK THROUGH A HOLE ON THE PAD SURFACE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED ARCTIC GEL NEONATAL PAD PRESENT WITH NO ORIGINAL PACKAGING. VISUAL INSPECTION NOTED THE FOLLOWING: NO OBVIOUS VISIBLE DEFECTS SUCH AS CUTS OR TEARS IN THE FOAM. NO VISIBLE CHIPS OR DEFORMITIES AT THE ENDS OF ALL CONNECTORS. TUBING FOR THE PAD NOTED NO KINKS PRESENT. HYDROGEL PEELED FROM THE SURFACE OF THE PAD WITH THE NONWOVEN TAPE FROM A BENT CORNER OF THE PAD. PR# (B)(4) WAS OPENED TO CAPTURE THIS FINDING. NO CRUSHED DIMPLES OR SIGNS OF OVERLAMINATION IN THE PADS. THE REPORTED ISSUE COULD NOT BE VERIFIED WITHOUT FURTHER TESTING. THE PAD WAS TESTED USING TM0301222 REV 3. AN AIR LEAK WAS FOUND THROUGH A HOLE ON THE HYDROGEL SIDE OF THE PAD THAT COULD BE SEALED WITH THE HYDROGEL. A STABLE FLOW RATE COULD NOT BE OBTAINED WHEN THE AIR LEAK WAS UNSEALED. WHEN SEALED, A TOTAL OF 1.3 L/MIN OF FLOW RATE WERE REGISTERED DURING THE TEST. ALSO, THE SYSTEM DIAGNOSTICS WERE REVIEWED, AND CIRCULATION PUMP COMMAND WAS 42%, INLET PRESSURE WAS -7.3 PSI. ACCORDING TO THE TEST METHOD TM0301222 REV 3 THE FLOW RATE WAS FOUND TO BE INADEQUATE FOR THE RETURNED PAD. (ACCEPTABLE RANGE >= 1.0 L/MIN). THE INSTRUCTIONS-FOR-USE UNDER BAW7667064 REV 0 ARE 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 THE IFU: "IF THE PAD FAILS TO PRIME OR A SIGNIFICANT CONTINUOUS AIR LEAK IS OBSERVED IN THE PAD RETURN LINE, CHECK THE CONNECTIONS, THEN IF NEEDED, REPLACE THE LEAKING PAD. ONCE THE PAD IS PRIMED, ASSURE THE STEADY STATE FLOW RATE DISPLAYED ON THE CONTROL PANEL IS APPROPRIATE. THE MINIMUM FLOW RATE SHOULD BE 1.1 L/M." A REVIEW OF THE DEVICE HISTORY RECORD AND MANUFACTURING CONTROLS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ADDITIONAL ACTIONS ARE REQUIRED. CORRECTIONS: D, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 THERE WERE ALARM 64 IN AN ARCTIC SUN DEVICE. THERE WAS AIR BUBBLE VISIBLE IN NEONATAL PAD PIPES. THERE WAS 1 NEONATAL PAD TO TAKE. INCIDENT OCCURRED DURING USE. HOSPITAL GAVE THEM CALL 09.04.2025 AT 23:07. THEY GO TO HOSPITAL AIR CAME FROM PAD 3180202, EXPIRATION DATE: 04/30/2026, LOT #NGJS4257. THEY CHANGE ARCTIC SUN AND ARCTIC SUN NEONATAL PAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ALARM 64 IN AN ARCTIC SUN DEVICE. THERE WAS AIR BUBBLE VISIBLE IN NEONATAL PAD PIPES. THERE WAS 1 NEONATAL PAD TO TAKE. INCIDENT OCCURRED DURING USE. HOSPITAL GAVE THEM CALL (B)(6) 2025 AT 23:07. THEY GO TO HOSPITAL AIR CAME FROM PAD 3180202 (B)(4). THEY CHANGE ARCTIC SUN AND ARCTIC SUN NEONATAL PAD. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 22APR2025, SN # (B)(6) PROVIDED, PATIENT HIPOTERMI WAS CONTINUED WITH DIFFERENT NEONATOLOGY PAD. NOT REPAIRED, PADS WERE PACKED AND WAITING FOR CARRIER, TO TAKE THEM FROM HOSPITAL. THEY WERE USED, PATIENT WAS IN HIPOTERMIA PROCESS, SAMPLE MAY BE CONTAMINATED. PER SAMPLE EVALUATION RESULTS ON 15OCT2025, HYDROGEL PEELED FROM THE SURFACE OF THE PAD WITH THE NONWOVEN TAPE FROM A BENT CORNER OF THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113717 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS NEONATAL ARCTIC GEL PADS DWJ MEDIVANCE -1725056 NGJS4257 00801741132131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other