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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
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE Back to Search Results
Device Problems Device Sensing Problem (2917); Protective Measures Problem (3015)
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.
 
Event Description
It was reported that the patient was above target while on the arcticsun device, and the device was displaying erratic temperature alarms.The patient was 37.6c, the target was 37c, the water temperature was 10.8c, and the flow rate was 2.6l/min.The event log showed alarms 15 (unable to obtain stable pt.Temp) and alert 50 (pt.Temp one erratic).Per troubleshooting, the nurse confirmed the probe correlated with the patient's temperature and she contacted the clinical manger to have the cable replaced.The nurse was called back and stated the device was switched and the patient was continuing therapy.Additional information was received on 15nov2019 from the nurse who stated that the patient completed therapy on the second device.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported issue could be a defective temperature cable.The lot number is unknown; therefore, a device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿main safety alarms while there are multiple alarms and safety features in the arctic sun® temperature management system, there are five main safety alarms that will place the device into stop mode until the condition is addressed.Alarm specification high patient temperature 39.5°c (103.1°f) low patient temperature 31.0°c (87.8°f) high water temperature 42.5°c / 44°c (108.5°f / 111.2°f) low water temperature 3.0°c / 3.5°c (37.4°f / 38.3°f) system self-test failure at device power on each time the arctic sun® temperature management system is powered on, a system self test for the independent safety alarm is automatically run.This test simulates a ¿water high temperature¿ fault situation on both the primary and secondary water temperature sensors.Both the primary and secondary safety systems must respond to the fault and be verified by the opposing safety system.If either safety systems do not respond appropriately either an alarm 80 or 81 will be issued.Contact customer support.Non-recoverable alarms if an alarm condition occurs that prevents proper use of the device or proper patient treatment (such as the five main safety alarms discussed above), the system is placed into stop mode and will not allow therapy to continue.This type of alarm is known as non-recoverable.If this situation occurs, cycle the device power (turn device off then on).If the alarm recurs contact customer support.Recoverable alarms other alarms that temporarily stop the device until the user is able to correct the cause and clear the alarm are classified as recoverable.If the condition that initiated the alarm is not addressed and problem persists, the alarm will recur.If a recoverable alarm occurs: 1) when an alarm is issued the device is placed into stop mode.2) read the displayed instructions.3) note the alarm number.4) press the close button to clear the alarm.5) follow the instructions to correct the alarm condition.Perform the actions in the order listed until the alarm condition is resolved.6) once you have cleared the alarm, press the start button in the therapy window to restart therapy.You will hear a tone and a voice stating ¿therapy started¿.Additionally, the active therapy window and the arctic sun® temperature management system icon will blink.7) if the condition does not resolve, contact customer support.Alerts alerts are denoted by an audio signal that repeats every 25 seconds.The alert screen will appear that displays the alert number, alert title, a description of the problem that triggered the alert, and solutions and instructions for troubleshooting and resolving the alert condition.If an alert occurs: 1) read the displayed instructions.2) note the alert number.3) press the close button to clear the alert.4) follow the instructions to correct the alert condition.Perform the actions in the order listed until the alarm condition is resolved.If the condition does not resolve, contact customer support.5) refer to the arctic sun® temperature management system help screens for additional information regarding alarms and alerts." 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 patient was above target while on the arcticsun device, and the device was displaying erratic temperature alarms.The patient was 37.6c, the target was 37c, the water temperature was 10.8c, and the flow rate was 2.6l/min.The event log showed alarms 15 (unable to obtain stable pt.Temp) and alert 50 (pt.Temp one erratic).Per troubleshooting, the nurse confirmed the probe correlated with the patient's temperature and she contacted the clinical manger to have the cable replaced.The nurse was called back and stated the device was switched and the patient was continuing therapy.Additional information was received on 15nov2019 from the nurse who stated that the patient completed therapy on the second device.
 
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Brand Name
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of Device
TEMPERATURE CABLE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9347578
MDR Text Key179259030
Report Number1018233-2019-07430
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,use
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
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 Received01/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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