BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 15362247 · Received September 6, 2022

    Report

    Report Number
    1018233-2022-06914
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 24, 2022
    Report Date
    February 6, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. 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 WAS PERFORMING PREVENTIVE MAINTENANCE AND THE ARCTIC SUN DEVICE WAS NOT COOLING. BIOMED ALREADY HEATED BUT COULD NOT COOL DOWN, CHILLER TEMPERATURE (T4) WAS 20C AND CONFIRMED THAT THERE WAS NOT ANY WATER IN THE CHILLER TANK INDICATING THAT THE MIXING PUMP HAD FAILED. BIOMED STATED THAT THEY HAD THE SPARE PARTS IN HOUSE AND WOULD REPLACE IT ONSITE. PER EMAIL RESPONSE RECEIVED ON 18-JULY- 2022, NO PATIENT INVOLVEMENT DURING REPORTED EVENT. PER SAMPLE EVALUATION RESULTS RECEIVED ON 24-AUG- 2022, THE ARCTIC SUN DEVICE WAS ORIGINALLY SHORT FILLED. IT WAS NOTED THAT THE CONTROL PANEL DID NOT BOOT UP BUT USED A USER INTERFACE TO COMPLETE DECONTAMINATION. IT WAS STATED THAT UPON INVESTIGATING, IT WAS DISCOVERED THAT THE BIOS COIN CELL WAS DEPLETED. IT WAS ALSO NOTED THAT BOTH THE DOUBLE BEND TUBE AND THE CHILLER EVAPORATOR OUTLET TUBE WERE FOUND TO BE EXPANDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIOMED WAS PERFORMING PREVENTIVE MAINTENANCE AND THE ARCTIC SUN DEVICE WAS NOT COOLING. BIOMED ALREADY HEATED BUT COULD NOT COOL DOWN, CHILLER TEMPERATURE (T4) WAS 20C AND CONFIRMED THAT THERE WAS NOT ANY WATER IN THE CHILLER TANK INDICATING THAT THE MIXING PUMP HAD FAILED. BIOMED STATED THAT THEY HAD THE SPARE PARTS INHOUSE AND WOULD REPLACE IT ONSITE. PER EMAIL RESPONSE RECEIVED ON 18JULY2022, NO PATIENT INVOLVEMENT DURING REPORTED EVENT. PER SAMPLE EVALUATION RESULTS RECEIVED ON 24AUG2022, THE ARCTIC SUN DEVICE WAS ORIGINALLY SHORT FILLED. IT WAS NOTED THAT THE CONTROL PANEL DID NOT BOOT UP, BUT USED A USER INTERFACE TO COMPLETE DECONTAMINATION. IT WAS STATED THAT UPON INVESTIGATING, IT WAS DISCOVERED THAT THE BIOS COIN CELL WAS DEPLETED. IT WAS ALSO NOTED THAT BOTH THE DOUBLE BEND TUBE AND THE CHILLER EVAPORATOR OUTLET TUBE WERE FOUND TO BE EXPANDED. PER SAMPLE EVALUATION RESULTS RECEIVED ON 24JAN2023, IT WAS REPORTED THAT THE TANK SEALS WERE REPLACED DUE TO LIFTING FROM THE TANK. IT WAS STATED THAT THE CHILLER MOLDED TUBE WAS REPLACED DUE TO DAMAGE FOUND DURING REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446635 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000E NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other