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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
Model Number 50000000E
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2023
Event Type  malfunction  
Event Description
It was reported that the biomed had replaced valves in the arctic sun device and was still getting a valve pressure error.Per sample evaluation results received on 03feb2023, the ac cca card showed signs of electrical overstress.The tank tubing was expanded and replaced due to normal wear as preventive maintenance.Replaced flow meter due to extensive hours as preventive maintenance.Per sample evaluation results received on 08feb2023, it was reported that the double bend tube and 1/2 l shaped tube were expanded.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported issue was confirmed.The device was evaluated and the reported issue was confirmed as it noted that the ac cca card showed signs of electrical overstress.Replaced cca ca card.Performed 2k pm service on the unit.Serviced the mixing, and circulation pumps.Replaced the heater # 1625, with new heater # 2151, drain valves.Performed a functional check and pre-cal the device after the repairs.Placed on acats (automated calibration and test system).Passed acats and document testing.Performed an electrical safety test.Passed electrical testing and documented testing.Completed the final inspection.The unit is functioning properly.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.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: inadequate verification and validation activities of the crimping process.Single pull test did not provide stability of process.Evidence was not provided when requested for maintenance of records or crimp tools.No crimp cross-sections provided.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The dhr review is not required and the labeling review is not required because labeling could not have prevented this issue.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.
 
Event Description
It was reported that the biomed had replaced valves in the arctic sun device and was still getting a valve pressure error.Per sample evaluation results received on 03feb2023, the ac cca card showed signs of electrical overstress.The tank tubing was expanded and replaced due to normal wear as preventive maintenance.Replaced flow meter due to extensive hours as preventive maintenance.Per sample evaluation results received on 08feb2023, it was reported that the double bend tube and 1/2 l shaped tube were expanded.
 
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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 Key16437514
MDR Text Key310250478
Report Number1018233-2023-01201
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 04/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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