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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE Back to Search Results
Catalog Number 50000000E
Device Problems Circuit Failure (1089); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2024
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was missing the locking lever on the manifold for the fluid delivery line (fdl).They stated that this was not a spare part and noted the device previously had for an unknown repair.Per sample evaluation results received on 29mar2024, it was reported that case data shows unit cooling issues, chiller power dead short to ac mains voltage circuit card.Ac mains voltage card now shorted as well.Chiller pump seal leaks at tank.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that the arctic sun device was missing the locking lever on the manifold for the fluid delivery line (fdl).They stated that this was not a spare part and noted the device previously had for an unknown repair.Per sample evaluation results received on 29mar2024, it was reported that case data shows unit cooling issues, chiller power dead short to ac mains voltage circuit card.Ac mains voltage card now shorted as well.Chiller pump seal leaks at tank.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause identified is a failed ac main voltage circuit card.The device was evaluated upon receipt.The chiller power dead short to ac mains voltage circuit card.Ac mains voltage card now shorted as well.Replaced ac main voltage circuit card.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.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.The complaint or 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.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key19058328
MDR Text Key339562093
Report Number1018233-2024-01912
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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