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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE; ARCTIC SUN TEMP CABLE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE; ARCTIC SUN TEMP CABLE Back to Search Results
Device Problems Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); 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 arctic sun temperature was erratic and the device was beeping.The temperature was reading 36.4 one moment and 34c the next.The temperature was reading via rectal probe.The complainant confirmed placement.Additional information was received from the facility on 24jan2020 that the device had been swapped and the temperature was reading without issue on a second device.He noted the cable had been the issue, but he could not remove the cable alone from the device.Additional information was received from the biomed on 27jan2020, that the cable was cut off and exchanged.The device worked properly after exchanging the cable and had been sent back into service.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue was a defective temperature cable.The device did not meet specifications, and was influenced by the reported failure.The temperature was reading 36.4 one moment and 34c the next.The temperature was reading via rectal probe, and the complainant confirmed placement.Per additional information, the device had been swapped and the temperature was reading without issue on a second device.He noted the cable had been the issue, but he could not remove the cable alone from the device.Per additional information was received from the biomed, the cable was cut off and exchanged.The device worked properly after exchanging the cable and has been sent back into service.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿functional verification perform the following functional verification procedure after initial setup and installation of the control module.1) power on the control module 2) from the patient therapy selection screen, press the hypothermia button to display the hypothermia therapy screen.3) from the hypothermia therapy screen, press the manual control button to open the manual control window.4) use the up and down arrows to set the manual control water target temperature to 40°c and the duration to 30 minutes.5) press the start button to initiate manual control.Allow at least 3 minutes for the system to stabilize.6) monitor the flow rate and water temperature in the system status area on the hypothermia therapy screen.7) verify that the flow rate reaches at least 1.5 liters/minute.8) verify that the water temperature increases to 30°c.9) press the stop button.10) set the manual control water target temperature to 4°c and the duration to 30 minutes.11) press the start button to initiate manual control.12) monitor the flow rate and water temperature in the system status area of the hypothermia therapy screen.Verify that the water temperature drops to 6°c.13) press the stop button to stop manual control 14) press the cancel button to close the manual control window 15) power off the control module." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the arctic sun temperature was erratic and the device was beeping.The temperature was reading 36.4 one moment and 34c the next.The temperature was reading via rectal probe.The complainant confirmed placement.Additional information was received from the facility on 24jan2020 that the device had been swapped and the temperature was reading without issue on a second device.He noted the cable had been the issue, but he could not remove the cable alone from the device.Additional information was received from the biomed on 27jan2020, that the cable was cut off and exchanged.The device worked properly after exchanging the cable and had been sent back into service.
 
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Brand Name
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of Device
ARCTIC SUN TEMP CABLE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9711879
MDR Text Key183360116
Report Number1018233-2020-01052
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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