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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 5000-01-01
Device Problems Circuit Failure (1089); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
It was reported that the alarm 77 (non-recoverable system error-chiller water temperature sensor out of range ¿ high resistance) has occurred in an arctic sun device.Per review of wo on 26feb2024, there was no patient involvement.Per follow up information received via email on 04mar2024, they repaired the device on the customer site.They replaced a tank harness, and the problem was resolved.Alarm 77 occurred continuously.Tank harness was defective and replaced a tank harness.
 
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 alarm 77 (non-recoverable system error-chiller water temperature sensor out of range ¿ high resistance) has occurred in an arctic sun device.Per review of wo on 26feb2024, there was no patient involvement.Per follow up information received via email on 04mar2024, they repaired the device on the customer site.They replaced a tank harness, and the problem was resolved.Alarm 77 occurred continuously.Tank harness was defective and replaced a tank harness.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed t4 thermistor.The device was evaluated upon receipt.Alarm 77 occurred.Tank harness was defective.Replaced tank harness.This device was evaluated for functionality.It passed all tests successfully.The evaluation found no other issues with the arctic sun performance.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The labelling review is not required as the 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 Key18886433
MDR Text Key337582707
Report Number1018233-2024-01278
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
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 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2011
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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