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

Catalog Number 60000000

Device Problems Insufficient Heating (1287); Overfill (2404)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

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 something happened on the night shift and the patient's temperature dropped to 30c in the arctic sun device.The water temperature was also around 30c.The target temperature was 33.5c.They got an alarm to add water and after that the patient's temperature dropped, and they got alert 113 (reduced water temperature control).They reinserted the rectal probe to confirm it was placed properly.The pad was wet, so they added an extra receiving blanket between the patient and the pad.Then the patient's temperature was 32.9c, flow rate was 1.4lpm, water flow rate was 39.7c.Confirmed alarm 5 (water reservoir level low) and alert 113.The water lever was 5.Suggested monitoring patient and water temperature.Explained how overfill could occur if the pads were not emptied prior to filling the reservoir.The nurse was not sure if pads were emptied first as they were not on shift.Nurse would like a representative to come out to do a data download and look at therapy data.The patient's temperature was dropping again, and the water temperature was not increasing.They were getting alert 113.The patient's temperature was 33.5c, rewarm from 34.3c, the water temperature was 23.6c, flow rate was 0.7lpm.Disconnected and reconnected pad using proper technique.The patient was in an isolated bed, but the tubing was going through a slot and was not kinked or twisted anywhere.Flow rate was 1.1lpm and the inlet pressure was -7.2psi.Heater command 100 percentage.The water temperature is not increasing.Drained excess water from the circulation tank.The water temperature increased to 35c while on the phone.Asked nurse to call back with any concerns but no further calls were received.

Event Description

It was reported that something happened on the night shift and the patient's temperature dropped to 30c in the arctic sun device.The water temperature was also around 30c.The target temperature was 33.5c.They got an alarm to add water and after that the patient's temperature dropped, and they got alert 113 (reduced water temperature control).They reinserted the rectal probe to confirm it was placed properly.The pad was wet, so they added an extra receiving blanket between the patient and the pad.Then the patient's temperature was 32.9c, flow rate was 1.4lpm, water flow rate was 39.7c.Confirmed alarm 5 (water reservoir level low) and alert 113.The water lever was 5.Suggested monitoring patient and water temperature.Explained how overfill could occur if the pads were not emptied prior to filling the reservoir.The nurse was not sure if pads were emptied first as they were not on shift.Nurse would like a representative to come out to do a data download and look at therapy data.The patient's temperature was dropping again, and the water temperature was not increasing.They were getting alert 113.The patient's temperature was 33.5c, rewarm from 34.3c, the water temperature was 23.6c, flow rate was 0.7lpm.Disconnected and reconnected pad using proper technique.The patient was in an isolated bed, but the tubing was going through a slot and was not kinked or twisted anywhere.Flow rate was 1.1lpm and the inlet pressure was -7.2psi.Heater command 100 percentage.The water temperature is not increasing.Drained excess water from the circulation tank.The water temperature increased to 35c while on the phone.Asked nurse to call back with any concerns but no further calls were received.Per customer via phone on 29jan2024, it was reported that therapy was completed and there was no impact to the patient.They had no other identifying information about the patient.Ther nurse could not provide any information regarding the complaint.The complaint came from another nurse and just reported the incident.The device did not go to biomed.

Manufacturer Narrative

Upon further review, bd has determined that this mdr is not reportable.The device was not returned.

• Brand Name: ARCTIC SUN STAT
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18426247
• MDR Text Key: 331896746
• Report Number: 1018233-2023-09405
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other