BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 23694115 · Received December 2, 2025

    Report

    Report Number
    1018233-2025-10639
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    August 4, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS COVERED UNDER CAPA #2666889 AND SA #(B)(4). PER CAPA #2666889 AND SA #(B)(4): "THE ROOT CAUSE IS AN INCORRECT TOOL USED TO MANUFACTURE THE DRAIN VALVE BODY COMPONENT THAT IS PURCHASED BY SUB-TIER SUPPLIER (B)(4) AND SUBSEQUENTLY PURCHASED BY (B)(6) FOR SALE TO BD. CPC SUPPLIER COMPLETED ACTIONS TO CORRECT THE DRAIN VALVE BODY COMPONENT 1186100C TOOL." PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON (B)(6) 2025, A DRAIN VALVE WAS TAKEN FROM A DECOMMISSIONED UNIT AND REPLACE THE VALVE IN UNIT SERIAL NUMBER (B)(6). THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. A DHR REVIEW IS NOT REQUIRED AS THE COMPLAINT IS ADDRESSED BY EXISTING CAPA. CAPA 2666889 HAS BEEN OPENED FOR THIS FAILURE. REFER TO THE CAPA FOR FURTHER ACTION. 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 THE BIOMED STATED RIGHT DRAIN PORT WAS MISSING THE PLUG AND WAS LEAKING WATER IN AN ARCTIC SUN DEVICE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON (B)(6) 2025, THEY WERE ABLE TO TAKE A DRAIN VALVE FROM A DECOMMISSIONED UNIT AND REPLACE THE VALVE IN UNIT SERIAL NUMBER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753731 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other