BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 20146205 · Received September 5, 2024

    Report

    Report Number
    1018233-2024-05564
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 27, 2024
    Report Date
    November 15, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080159
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A FAILED CIRCULATION PUMP. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. A DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. 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 DURING EVALUATION IT WAS FOUND THAT THE ARCTIC SUN DEVICE WAS UNABLE TO MEASURE FLOW. INTERNAL PRESSURE WAS VERIFIED READING -7PSI (-10.2PSI), BUT A FLOW OF 0 PERSISTED. THE FLOW METER WAS RESET, BUT THE PROBLEM PERSISTED. A FLOW READING OF 10 ML/M WAS OBTAINED MOMENTARILY, THEN THE READING WENT BACK DOWN TO 0. PER SAMPLE EVALUATION RESULTS ON 27AUG2024, IT WAS REPORTED THAT THE CIRCULATION PUMP MOTOR HAD WORK OUT BEARINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EVALUATION IT WAS FOUND THAT THE ARCTIC SUN DEVICE WAS UNABLE TO MEASURE FLOW. INTERNAL PRESSURE WAS VERIFIED READING -7PSI-(-10.2PSI), BUT A FLOW OF 0 PERSISTED. THE FLOW METER WAS RESET, BUT THE PROBLEM PERSISTED. A FLOW READING OF 10 ML/M WAS OBTAINED MOMENTARILY, THEN THE READING WENT BACK DOWN TO 0. PER SAMPLE EVALUATION RESULTS ON 27AUG2024, IT WAS REPORTED THAT THE CIRCULATION PUMP MOTOR HAD WORK OUT BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140831 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other