BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 17799057 · Received September 22, 2023

    Report

    Report Number
    1018233-2023-07012
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 5, 2023
    Report Date
    November 29, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A FAILED HEATER. THE ARCTIC SUN 5000 WAS EVALUATED. DURING SERVICE, TECH DID NOT FIND ANY VALUES DURING RESISTANCE MEASUREMENT FOR THE HEATER. HEATER WAS REPLACED. A REVIEW OF THE DHR DID NOT SHOW AND PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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. H3 OTHER TEXT : 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 ARCTIC SUN DEVICE WAS GIVING LOW FLOW, ERROR 41 (LOW INTERNAL FLOW). PER REVIEW OF WO ON 19 AUG 2023, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP REVIEW OF WO ON 01 SEP 2023, THE MIXING PUMP ASSY, CIRCULATION PUMP ASSY, HEATER AND DRAIN VALVE WILL BE REPLACED. ALL TESTS PERFORMED ACCORDING TO PROCEDURE. THE EQUIPMENT HAS BEEN VISUALLY EXAMINED AND FOUND TO BE FREE OF PHYSICAL DAMAGE. LOW FLOW CAUSED BY CONSIDERED A FAILURE IN THE MIXING PUMP, IT WAS IDENTIFIED IN THE MACHINE THAT THE EQUIPMENT WAS NOT USED FOR A LONG TIME. PER SAMPLE EVALUATION RESULTS ON 29 AUG 2023, IT WAS REPORTED THAT THE DRAIN PORTS WERE CLOGGED. DEVICE UNDERWENT 2000 PREVENTIVE MAINTENANCE. PER SAMPLE EVALUATION RESULTS ON 05 SEP 2023, IT WAS REPORTED THAT THE FAILED HEATER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS GIVING LOW FLOW, ERROR 41 (LOW INTERNAL FLOW). PER REVIEW OF WO ON (B)(6) 2023, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP REVIEW OF WO ON 01SEP2023, THE MIXING PUMP ASSY, CIRCULATION PUMP ASSY, HEATER AND DRAIN VALVE WILL BE REPLACED. ALL TESTS PERFORMED ACCORDING TO PROCEDURE. THE EQUIPMENT HAS BEEN VISUALLY EXAMINED AND FOUND TO BE FREE OF PHYSICAL DAMAGE. LOW FLOW CAUSED BY CONSIDERED A FAILURE IN THE MIXING PUMP, IT WAS IDENTIFIED IN THE MACHINE THAT THE EQUIPMENT WAS NOT USED FOR A LONG TIME. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2023, IT WAS REPORTED THAT THE DRAIN PORTS WERE CLOGGED. DEVICE UNDERWENT 2000 PREVENTIVE MAINTENANCE. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2023, IT WAS REPORTED THAT THE FAILED HEATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873208 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other