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

Model Number 50000000

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

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

Event Date 10/10/2022

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 arctic sun device had a non-recoverable system error , but they turned the device off and then back on, filled it, and now it was working fine.They were using the device for normothermia.Mss asked if nurse tried to clear the low reservoir alert before filling, nurse said no.Mss confirmed that the patient temperature was 35.9c, water temperature was 27.5c, target temperature was 37c and flow rate was 3.6lpm.Mss discussed possible overfill because the water temperature should be warmer since patient temperature was 1.1c below target.Mss had nurse to disconnect abruptly due to patient condition.Nurse said that they had time to drain water but not much more.Mss walked nurse through draining 500ml from right drain port.Water temperature jumped up to 34.6c by end of call.Mss advised nurse to call back if water temperature did not continue to rise, or patient temperature did not reach target temperature.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is an overfilled reservoir.Earlier upon receiving a reported non-recoverable system error, they had turned the device off and then back on, filled it, and now it was working fine.It is known that the device did not meet specifications and that the device was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The serial number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "fill reservoir fill the reservoir with sterile water only.Four liters of water will be required to fill the reservoir at initial installation.Add one vial of arctic sun® temperature management system cleaning solution to the sterile water.From the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.From the hypothermia or normothermia therapy screen, press the fill reservoir button.The fill reservoir screen will appear.Follow the directions on the screen." h11: section a through f the information provided by bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the arctic sun device had a non-recoverable system error , but they turned the device off and then back on, filled it, and now it was working fine.They were using the device for normothermia.Mss asked if nurse tried to clear the low reservoir alert before filling, nurse said no.Mss confirmed that the patient temperature was 35.9c, water temperature was 27.5c, target temperature was 37c and flow rate was 3.6lpm.Mss discussed possible overfill because the water temperature should be warmer since patient temperature was 1.1c below target.Mss had nurse to disconnect abruptly due to patient condition.Nurse said that they had time to drain water but not much more.Mss walked nurse through draining 500ml from right drain port.Water temperature jumped up to 34.6c by end of call.Mss advised nurse to call back if water temperature did not continue to rise, or patient temperature did not reach target temperature.

• 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: 15631406
• MDR Text Key: 306598181
• Report Number: 1018233-2022-07966
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/16/2023
• 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