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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Infusion or Flow Problem (2964); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
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 evaluated by a biomedical technician at the complainant's facility.
 
Event Description
It was reported that the arcticsun device was getting a low flow alert (alert 02) during therapy. The patient's temperature of 32. 7c was below the target temperature of 33. 5c. The flow rate was reading 0. 0l/min. No water was seen flowing through the pad connector sites. Per troubleshooting with ms&s, the event log showed the alert 02 as well as an alert 113 (reduced water temperature control). The nurse stated that the patient started therapy in the emergency department and was transferred to the intensive care unit with the device. The nurse tried disconnecting and reconnecting the pads with no change in flow rate. The nurse was then instructed to take off the fluid delivery line and run diagnostics. The flow rate read 1. 9-2. 2l/min, inlet pressure was in the -12psi range, and the circulation pump command was in the 40% range. Reconnection of the fluid delivery line yielded no change in flow rate. The nurse had drained 400cc of water from the device to test the heater, but the heater could not be tested due to the low flow. Additional information was received from the facility on 22may2019, that the device was swapped and the second device gave the same alerts. They did additional troubleshooting on both devices and the patient was placed back on the first device. The second device was sent to the biomed, and the patient was continuing therapy successfully on the first device with the same set of pads with no further issue. Additional information was received via voice message from the biomed on 23may2019 stating that the second device was found to be low on water. After refilling, the device functioned normally and was placed back in service.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN 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 Key8683094
MDR Text Key148311610
Report Number1018233-2019-02999
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
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2019
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 Received07/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2011
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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