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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 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient was not getting to the target of 33c as quickly as expected on the arctic sun device. The nurse confirmed that the patient temperature was 36. 3c, target temperature was 33c, water temperature was 5. 8c and flow rate was 2. 1lpm. Event log showed alert 0052 (extended period of cold water) which correlated with the therapy start time. According to nurse, the therapy started last night around 11. 00pm. Nurse stated that the device had an alert 01/02 (patient line open /low flow). They have stopped the therapy, emptied the pads, disconnected, and reconnected with proper technique. The therapy was resumed, and no alerts were received. System diagnostics showed water level was 4, inlet pressure was -7. 2psi, circulation pump command was 65percentage, mixing pump command was 100percentage, system hours were 2679 and pump hours were 2437. Trend indicator showed thermoneutral. Mss explained that the device appeared to be working appropriately now. Also discussed non-pharmacological interventions such as bair hugger to help with heat generation and advised nurse to look at hospital protocol regarding options for pharmacological interventions based on patient's bsas and temperature.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13168581
MDR Text Key284714334
Report Number1018233-2021-08690
Device Sequence Number1
Product Code DWJ
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
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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