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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 Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problems Cardiac Arrest (1762); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
 
Event Description
It was reported that there was suboptimal flow and the water temperature was fluctuating. The nurse reported that the patient was (b)(6) year old and post cardiac arrest post seizure. The patient's temperature was in the 38c range, the target temperature was 36c, and the water temperature was 29c. She stated she was seeing many air bubbles in the line. Per troubleshooting, it was explained that if the device was not alarming air bubbles, then it was not a concern. The nurse stated she was seeing the water temperature fluctuate. During the call the nurse reported that there was an alarm for suboptimal flow. The flow rate was 1. 5 l/min. She was advised to stop therapy, empty the pads, disconnect and reconnect the pads using the proper technique. The flow rate was in the 3 l/min range. The nurse checked the patient's temperature with an alternate source and she noted that it correlated. It was explained that the flow rate was optimal, the temperatures correlated and the water temperature was decreasing in order to bring down the patients temperature. Per additional information, therapy was stopped and the patient was taken off of the device. Per additional information, the nurse stated that therapy was stopped and the patient was taken off of the device because the patient was not cooling. She said the patient's temperature rose to 102f, so they ended up packing the patient with ice and wrapped them in a cooling blanket.
 
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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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7481356
MDR Text Key107517210
Report Number1018233-2018-01444
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 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
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 Received06/18/2018
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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