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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 Problems Failure to Pump (1502); Protective Measures Problem (3015); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient was not cooling on the arctic sun device. Complainant stated they had been receiving an alert 113 about every three minutes since around 1pm. Patient was 36. 1c, target was 36c, water was 28. 6c and flow rate was 1. 1 l/m. Pads were medium and there was some exposed area. Complainant disconnected and reconnected pads before calling and flow had been lower since the alert 113 started. T1 was 36. 1 c, t3 was 28. 6c, t4 was 4. 3c, water flow rate (wfr) was 1. 1 l/m, inlet pressure was -7 psi, circulation pump was 36%, mixing pump was 100% and water reservoir level (wrl) was 4. System hours were 5864. 9 and pump hours were 5223. 3. Ms&s advised nurse to swap out device. Complainant confirmed they have another device available on the floor that they can use. Biomed called later that day to troubleshoot the alert 113. Biomed placed the device in manual control and the water was full. The device heated to 42c. In manual control the device read: t1 at 38c, t2 at 38c, t4 at 3. 9c, and mixing pump at 100%. Call transferred to tech support. As per follow up information, the patient was continuing therapy with no further issues on the second device. First device was with biomed and confirmed a failed mixing pump. The device will be returned to the depot for a preventive maintenance.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10339197
MDR Text Key222831276
Report Number1018233-2020-04832
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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