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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 Restricted Flow rate (1248); Improper Flow or Infusion (2954); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Patient Involvement (2645); 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.
 
Event Description
It was reported that there was low flow on the arctic sun device. The device was maintaining patient temperature at 34c. Now the patient temperature was 34. 1c. The device was working fine but over the past hours the flow rate was 0. 7lpm. The nurse disconnected and reconnected the pads using the proper technique with no flow improvement. They ran diagnostics then the flow rate was 2. 4lpm, inlet pressure was -8 psi and the circulation pump command was at 80%. Reconnected pads using proper technique and the issue seemed to be with the trunk pads. Ms&s suggested to try on a second device and if flow was still low switch out the pads. The nurse called back an hour later and with a second device, the flow was the same so they kept the patient on the first device. Reconnected pads using proper technique, issue seemed to be with the trunk pads. Suggested trying a second device and if still low flow to switch out pads. Called back an hour later and with a second device flow was the same so they kept the patient on first device. The attending does not want to switch out the pads since the patient was maintaining target temperature. Ms&s explained to nurse that with flow rate too low the heater will not kick in if the patient dips below the target. In addition, the pads had been in use for 5 days. Ms&s explained that pads are supposed to be switched out every 5 days and would discussed changing the pads again with attending. The biomed received the device and stated that they attempted to drain the device but no water camed out. The water level showed 3 bars.
 
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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 Key10155250
MDR Text Key195722593
Report Number1018233-2020-03843
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
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

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