BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 17757128 · Received September 15, 2023

    Report

    Report Number
    1018233-2023-06817
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 24, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    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 REPORTED ISSUE WAS CONFIRMED. THE OVERHEATING OF THE WIRES WAS ASSESSED BY THE INVESTIGATION TASKS AND USED TO COMPLETE THE ROOT CAUSE EVALUATION USING THE FISHBONE METHODOLOGY (REFER TO AC CCA POWER INLET MODULE POWERPOINT FOR FISHBONE DIAGRAM). IT WAS CONCLUDED THAT THE FOLLOWING WAS THE ROOT CAUSE: SUPPLIER ¿ ROOT CAUSE O INADEQUATE VERIFICATION AND VALIDATION ACTIVITIES OF THE CRIMPING PROCESS O SINGLE PULL TEST DID NOT PROVIDE STABILITY OF PROCESS O EVIDENCE WAS NOT PROVIDED WHEN REQUESTED FOR MAINTENANCE OF RECORDS OR CRIMP TOOLS O NO CRIMP CROSS-SECTIONS PROVIDED THE DHR REVIEW IS NOT REQUIRED. THE LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. 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. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 HAD THE ARCTIC SUN DEVICE WITH A DARK SCREEN AND THE SCREEN WAS NOT POWERED ON. PER SAMPLE EVALUATION RESULTS ON 24AUG2023, IT WAS REPORTED THAT THE SALES REPRESENTATIVE STOPPED IN AN UPDATED THE SOFTWARE BECAUSE THE CONTROL PANEL SOMETIMES WOULD COME ON AND IT WAS RUNNING SOFTWARE 2.0, IT WAS UPDATED TO 3.0.1 AND THE ISSUE STILL CONTINUED. THE BIOMED SAID THAT AFTER THE UPDATE THEY NOTICED THE DEVICE WOULD SOMETIMES POWER ON AND OTHER TIMES IT WOULD NOT TURN ON AT ALL, MEANING THEY COULD NOT HEAR THE PUMPS, FAN OR CHILLER RUNNING AND WONDERED IF THE ISSUE WAS WITH A POWER SUPPLY, THEY WERE WORKING ON BRINGING IT BACK FOR ASSESSMENT. THE ARCTIC SUN DEVICE WAS INTERMITTENTLY DID NOT POWER ON. UNIT DID POWER ON. RESTART UNIT AND DID NOT POWER ON. INSTALL TEST POWER SUPPLY, UNIT POWERED ON AND OFF SEVERAL TIMES AND FUNCTIONED PROPERLY. GRAPHICS WERE 3.0.2. CCA CA CARD TERMINALS SHOWS SIGNS ON ELECTRICAL OVER STRESS. UNIT HAD OVER 2000 PUMP HOURS SINCE LAST RECORDED 2 K PM. UNIT WAS NOT BOOTING UP, UNTIL CARD CAGE WAS WIGGLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIOMED HAD THE ARCTIC SUN DEVICE WITH A DARK SCREEN AND THE SCREEN WAS NOT POWERED ON. PER SAMPLE EVALUATION RESULTS ON 24AUG2023, IT WAS REPORTED THAT THE SALES REPRESENTATIVE STOPPED IN AN UPDATED THE SOFTWARE BECAUSE THE CONTROL PANEL SOMETIMES WOULD COME ON AND IT WAS RUNNING SOFTWARE 2.0, IT WAS UPDATED TO 3.0.1 AND THE ISSUE STILL CONTINUED. THE BIOMED SAID THAT AFTER THE UPDATE THEY NOTICED THE DEVICE WOULD SOMETIMES POWER ON AND OTHER TIMES IT WOULD NOT TURN ON AT ALL, MEANING THEY COULD NOT HEAR THE PUMPS, FAN OR CHILLER RUNNING AND WONDERED IF THE ISSUE WAS WITH A POWER SUPPLY, THEY WERE WORKING ON BRINGING IT BACK FOR ASSESSMENT. THE ARCTIC SUN DEVICE WAS INTERMITTENTLY DID NOT POWER ON. UNIT DID POWER ON. RESTART UNIT AND DID NOT POWER ON. INSTALL TEST POWER SUPPLY, UNIT POWERED ON AND OFF SEVERAL TIMES AND FUNCTIONED PROPERLY. GRAPHICS WERE 3.0.2. CCA CA CARD TERMINALS SHOWS SIGNS ON ELECTRICAL OVER STRESS. UNIT HAD OVER 2000 PUMP HOURS SINCE LAST RECORDED 2 K PM. UNIT WAS NOT BOOTING UP, UNTIL CARD CAGE WAS WIGGLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040845 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other