BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 12813495 · Received November 15, 2021

    Report

    Report Number
    1018233-2021-07234
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 19, 2021
    Report Date
    June 28, 2022
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED, AS THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING EVALUATION. NO ERRORS DETECTABLE IN THE DEPOT. DEVICE WORKED WITHOUT ANY PROBLEMS. AFTER SEVERAL ATTEMPTS (APPROX. 15 TIMES) TO FILL THE WATER, THE UNIT WAS ALWAYS COMPLETELY FILLED. THE DEVICE PASSED THE PROCEDURE AND CAN BE PLACED BACK INTO NORMAL USE. IT IS UNKNOWN IF THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE, HOWEVER THE DEVICE MET SPECIFICATIONS DURING EVALUATION. THE DEVICE WAS NOT IN USE ON A PATIENT. THE DEVICE HISTORY RECORD REVIEW AND LABELING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED AND NOT A MANUFACTURING OR SUPPLIER RELATED FAILURE. CORRECTIONS: D, G, H. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ONLY SUCKED IN APPROXIMATELY 1 TO 1.5 LITERS DESPITE SEVERAL ATTEMPTS AND REPLACEMENT OF THE LEVEL SENSOR, I/O CARD AND MIXING PUMP, AS WELL AS TANK CLEANING. AFTER RESTARTING, THE DEVICE APPROXIMATELY SHOWED 0.5 LITERS AGAIN. THE TANK COULD BE EMPTIED COMPLETELY AND THE ALARM 05 (WATER RESERVOIR EMPTY) TANK EMPTY APPEARED ALWAYS. PER FOLLOW UP INFORMATION RECEIVED ON 08NOV2021, THIS APPEARED DURING THE ORIGINAL REPAIR AND JUST GOT SWITCHED TO A DEPOT REPAIR, WHERE NOTHING WAS FOUND. PER REVIEW OF THE WORK ORDER, THE NOTE OF LEVEL SENSOR DEFECTIVE WAS THE ASSUMED CAUSE OF THE INACCURATE WATER LEVEL DETECTION. THE TECH REPLACED LEVEL SENSOR, I/O AND PUMP WITHOUT RESOLVING THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ONLY SUCKED IN APPROXIMATELY 1 TO 1.5 LITERS DESPITE SEVERAL ATTEMPTS AND REPLACEMENT OF THE LEVEL SENSOR, I/O CARD AND MIXING PUMP, AS WELL AS TANK CLEANING. AFTER RESTARTING, THE DEVICE APPROXIMATELY SHOWED 0.5 LITERS AGAIN. THE TANK COULD BE EMPTIED COMPLETELY AND THE ALARM 05 (WATER RESERVOIR EMPTY) TANK EMPTY APPEARED ALWAYS. PER FOLLOW UP INFORMATION RECEIVED ON 08NOV2021, THIS APPEARED DURING THE ORIGINAL REPAIR AND JUST GOT SWITCHED TO A DEPOT REPAIR, WHERE NOTHING WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710554 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other