MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 50000000E

Device Problem Alarm Not Visible (1022)

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

Event Date 11/11/2023

Event Type  malfunction  

Event Description

It was reported that the patient was in hypothermia.Cooling patient and the arctic sun device had been beeping without an actual message.Patient temperature was 32.6c, targeted temperature was 33c, water temperature was 33.1c and water flow rate was 2.8 l/m.Walked through accessing event log which showed last alert as 11 patient temperature 1 below low patient alert.Nurse noted that alert was the most recent but based on time it could not be the alert that came up.Checked low patient temperature settings which was 31c.Nurse stated they did not believe patient temperature was dropped that low, but about 45 minutes ago they did receive a message about an erratic temperature.Esophageal probe was in use and placement verified.Discussed secure connections between probe and cable, cable and device.Noted if erratic temperature or unstable patient temperature alerts occur, they should call back to trouble shoot cable.Stopped the therapy, emptied the pads and power device off and back on.Restarted therapy and no more audible alerts.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.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 in hypothermia.Cooling patient and the arctic sun device had been beeping without an actual message.Patient temperature was 32.6c, targeted temperature was 33c, water temperature was 33.1c and water flow rate was 2.8 l/m.Walked through accessing event log which showed last alert as 11 patient temperature 1 below low patient alert.Nurse noted that alert was the most recent but based on time it could not be the alert that came up.Checked low patient temperature settings which was 31c.Nurse stated they did not believe patient temperature was dropped that low, but about 45 minutes ago they did receive a message about an erratic temperature.Esophageal probe was in use and placement verified.Discussed secure connections between probe and cable, cable and device.Noted if erratic temperature or unstable patient temperature alerts occur, they should call back to trouble shoot cable.Had them press stop therapy, empty pads and power device off and back on.Restarted therapy and no more audible alerts.Per additional information via phone on 28dec2024, nurse confirmed patient completed therapy on same device with no further issues.Unable to confirm patient information.Unsure about cable status.No further information known.

• Brand Name: ARCTIC SUN® 5000
• 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: 18216891
• MDR Text Key: 329127655
• Report Number: 1018233-2023-08570
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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