• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Overfill (2404); Device Sensing Problem (2917)
Patient Problems Bradycardia (1751); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 the patient reached the target temperature of 33 c, however the patient's temperature rose to 33. 4 c and the patient was shivering. Sedatives and paralytics were administered. After the administration of the medication, the patient's temperature dropped below the target temperature to 32. 3 c. The water temperature was noted at 23 c and the trend indicator showed one arrow down. The complainant advised therapy stopped due to the patient's bradycardia. Per troubleshooting, manual control was enabled and the water temperature was set to 40 c for thirty minutes. System diagnostics showed the reservoir at level 5, so the nurse was walked through draining 500 mls of water from the right drain port. T1 and t2 quickly went from 25 c to 40 c. T4 was noted at 4. 2 c. It was explained that the device was overfilled, which prevented the water from heating when the patient's temperature dropped below target. Manual control was then disabled and therapy restarted. The flow rate settled at 2. 6 l/min and the nurse advised she would add a bair hugger. An additional call was placed to ms and s several hours later with the nurse stating the patient dropped below the target temperature to 32. 1 c. The trend indicator still showed one arrow down. While troubleshooting, the water temperature went from 31 c to 40 c, there was good fit to pads, good flow, and the device was responding appropriately to bring the patient's temperature back up to target temperature. An additional call was received from the complainant to ms&s approximately fourteen hours later advising that the device received an alert 113. The patient's temperature was 36. 4 c, the water temperature was 13. 2 c, and the flow rate was noted at 1. 7 l/min. Four large pads were in place. Per troubleshooting, the patient was set to rewarm from 35. 3 c at a rate of 0. 25 c to 37 c. The trend indicator was neutral, since the patient shivered intermittently a bair hugger was in place. The complainant was advised to send the device to biomed due to the alert 113 and replace with a second device. The complainant was walked through setting up the second device and adjusting the rewarm from to the current patient temperature of 36. 2 c. Per follow up with the facility on 06/29/2018, therapy continued on the second device with no further issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7695770
MDR Text Key114290721
Report Number1018233-2018-02851
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 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
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 Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
-
-