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

Model Number 50000000

Device Problems Use of Device Problem (1670); Power Problem (3010)

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

Event Date 11/06/2021

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 a normothermia patient was on the arctic sun device with a target of 37c.The device alarmed and powered off.The device alerted that it needed water so sterile saline was added and the device took less than 1 liter.Nurse just realized that they should have added sterile water and not sterile saline.The patient temperature was 35.9c, water temperature was 24.1c and flow rate was 3lpm.The event log showed an alert 45 (ac power lost), one alert 05 (water reservoir empty) and there were no other alarms or alerts.The device was plugged into the bed and mss explained that the device must be plugged into a wall outlet and not the bed.The pads were not emptied before water was added and they drained 500 ml from the right drain port.Now the water temperature was rising and mss explained that the device was overfilled as pads were not emptied before water was added.Mss recommended the nurse to contact the biomedical engineering department so they can drain the device to remove the saline and fill with sterile water and cleaning solution.The water temperature was up to 40c by the end of the call and a bair hugger in place.

Manufacturer Narrative

The reported issue was confirmed.No sample was returned for evaluation.The root cause of the reported issue was device plugged into incorrect outlet.The device did not meet specifications and was influenced by the reported failure.The device was in use on a patient.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1) use only medivance cables and accessories with the arctic sun® temperature management system control module.Connect the fluid delivery line, patient temp 1 cable, patient temp 2 cable (optional) and fill tube to the back of the control module.2) plug the power cord into the wall outlet.Position arctic sun® temperature management system so that access to the power cord is not restricted." 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.

Event Description

It was reported that a normothermia patient was on the arctic sun device with a target of 37c.The device alarmed and powered off.The device alerted that it needed water so sterile saline was added and the device took less than 1 liter.Nurse just realized that they should have added sterile water and not sterile saline.The patient temperature was 35.9c, water temperature was 24.1c and flow rate was 3lpm.The event log showed an alert 45 (ac power lost), one alert 05 (water reservoir empty) and there were no other alarms or alerts.The device was plugged into the bed and mss explained that the device must be plugged into a wall outlet and not the bed.The pads were not emptied before water was added and they drained 500 ml from the right drain port.Now the water temperature was rising and mss explained that the device was overfilled as pads were not emptied before water was added.Mss recommended the nurse to contact the biomedical engineering department so they can drain the device to remove the saline and fill with sterile water and cleaning solution.The water temperature was up to 40c by the end of the call and a bair hugger in place.Per follow up via phone on 30nov2021, nurse stated that the therapy was able to be completed with no further issues.There was no impact to the patient and the arctic sun device did not need to be repaired.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12870582
• MDR Text Key: 283791987
• Report Number: 1018233-2021-07533
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• 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
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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