Arctic Sun Stat

Description of Event or Problem

It was reported that the Arctic Sun device turned off STAT mode due to the patient becoming very cold during the night shift. The patient was febrile at the time and the team requested troubleshooting of the device.Per additional information received via TTM on 27 July 2026 the patient temperature was 38.2 C and the target temperature was 36.5 C. The device was turned back on and the user was guided to the event log. Several alerts were noted including Alert 7 (Empty Pads Not Complete) Alert 113 (Reduced Water Temperature Control), and Alert 45 (AC Power Lost). The flow rate was only 0.3 LPM upon restart. It was explained that the low flow could trigger Alert 113. The user was guided to the system diagnostics which showed SH 511 pump channel 415 inlet pressure (IP) of negative 6.9 psi. circulation pump command (CPC) of 35 percent, and water level 5. The pads were disconnected and reconnected using proper technique however, there was no change in the flow rate. When an attempt was made to empty the pad to replace it a Failure to Empty Pads alert was received. The device was planned to be sent to Biomed, and a new device was to be tried before replacing the pad.

Additional Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.UDI format updated with available product information per GUDID.H11: Section A through F - The information provided by BD represents all 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.