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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Insufficient Heating (1287); Use of Device Problem (1670); Overfill (2404)
Patient Problem 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 biomed received an arctic sun device with a note on it stating that the device would not heat the water. The reservoir level was showing five bars, and there were multiple alert 113s (reduced water temperature control) in the event log. Per troubleshooting with ms&s, the biomed was walked through draining and refilling the device with the same water. The device was over filled by 500ml. Manual control was enabled with the water temperature set to 40c for 30 minutes. T1 and t2 were 19. 1c but quickly rose to 37c. T4 was 5. 8c. With only the fluid delivery line attached, the flow rate was 1. 6l/min, the inlet pressure was -7psi, and the circulation pump command was 54%. The pump hours were noted at 4676 and system hours noted at 4869. Manual control was disabled.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCITC 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 Key8773061
MDR Text Key150592348
Report Number1018233-2019-03746
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 health professional,other,use
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2016
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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