Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-

FDA device recall Z-2457-2024 · posted 2024-07-31 · Open, Classified

Recall details

Recalling firm

Medivance Inc.

Reason for recall

If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

Action taken

On 6/27/24, correction notices were sent to customers and distributors informing them of the following: Advice for Clinical Users: 1) Systems contains the following two fixed alarms when the device is operating in patient control mode: - Alarm 10 will alert if the patient s temperature and/or water temperature is below 31 degrees Celsius and the water temperature is below 31 degrees Celsius. - Alarm 08 will alert if the patient s temperature and/or water temperature is above 39.5 degrees Celsius. 2) Customers should continue to use the customizable Patient Temperature Low (Alarm 11) and Patient Temperature High (Alarm 09) alarms on their devices. Both alarms are available when the device is operating in patient control mode. Customers should set these alarms to the lowest and highest temperatures they feel are acceptable for the specific patient being treated. Default settings are 30 degrees Celsius and 44 degrees Celsius and alert independent of water temperature. For Arctic Sun STAT, refer to the Operator Manual for Alarm 9 on page 39 and Alarm 11 on page 40. For Arctic Sun 5000, refer to the Service Manual for Alarms 9 and 11 on page 9. 3) As instructed in the Operating Manual, always empty Arctic Gel Pads when therapy is ended, even if the stop in therapy is only temporary. Failure to do so may result in overfill of the water reservoir and this can affect temperature management. -Complete and return the response form via email to BDRC40@bd.com -Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred, to ensure they are also aware of this Medical Device Recall. -Firm is developing a software update and will provide an additional communication with the status of the software update release by February 28, 2025. If you have any questions, contact the firm's Medical Information Services that are available 24/7 at 1-866-840-9776.

Root cause

Software design

Status

Open, Classified

Product code

DWJ

Quantity affected

10507

Distribution

Worldwide - US Nationwide distribution including in the states of IN, OK, MO, FL, CT, KS, TX, NJ, CA, OR, HI, IL, WI, VA, KY, NH, CO, NV, LA, NC, ID, UT, GA, SC, TN, MD, PA, IA, MA, OH, NY, DE, MI, NM

Date initiated

2024-06-27

Date posted

2024-07-31

Location

Louisville, CO

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