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

Model Number 50000000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/05/2022

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 nurse had a patient cooling on arctic sun device around 1am on (b)(6) 2022.Nurse stated that the device was sounding alert 113 (reduced water temp control), patient temperature was 32.5c, water temperature was 29.8c, flow rate was 3.1l/min, target temperature was 33c, reservoir level was 5 and heater command was 0 percent.Mss walked the nurse through draining 500 mls of water from the right drain port.Nurse stated that the water did not initially drain so they reversed the fill tubing, fine sediment initially came out and then the water cleared and started to flow out.Additional information received on (b)(4) 2022 around 11pm, hypothermia patient was cooling on arctic sun device with 1 hour left before rewarming began.Nurse reported that the device had been giving alert 113 (reduced water temp control) again this evening.Last night device was giving same alarm and 500 mls of water was drained.Nurse stated that the device worked fine all day but tonight the device is giving alert 113(reduced water temp control) again, patient temperature was 32.9c, water temperature was 30.8c, flow rate was 3l/min, target temperature was 33c.Mss recommended nurse to change out the device and label this one with alert 113 (reduced water temp control) and send this one for repair.Nurse had another device available.Mss explained that nurse needed to empty the pads into this device before changing to the new device.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to user related.Patient temperature was 32.5c, water temperature was 29.8c, flow rate was 3.1l/min, target temperature was 33c, reservoir level was 5 and heater command was 0 percent.Mss walked the nurse through draining 500 mls of water from the right drain port.It is known that the device did not meet specifications and the device was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The device history record review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.The instructions for use were found adequate and state the following: "replenish internal cleaning solution contact medivance customer service to order internal cleaning solution.1) drain the reservoir.¿ turn control module power off.¿ attach the drain line to the two drain valves on the back of the control module.Place the end of the drain line into a container.The water will passively drain into the container.2) refill the reservoir.¿ from the hypothermia therapy screen or the normothermia therapy screen, press the fill reservoir button.¿ the fill reservoir screen will appear.Follow the directions on the screen.¿ add one vial of arctic sun® temperature management system cleaning solution to the first bottle of sterile water.¿ the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.¿ when the fill reservoir process is complete, the screen will close." corrections: f,g,h 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 nurse had a patient cooling on arctic sun device around 1am on (b)(6)2022.Nurse stated that the device was sounding alert 113 (reduced water temp control), patient temperature was 32.5c, water temperature was 29.8c, flow rate was 3.1l/min, target temperature was 33c, reservoir level was 5 and heater command was 0 percent.Mss walked the nurse through draining 500 mls of water from the right drain port.Nurse stated that the water did not initially drain so they reversed the fill tubing, fine sediment initially came out and then the water cleared and started to flow out.Additional information received on (b)(6)2022 around 11pm, hypothermia patient was cooling on arctic sun device with 1 hour left before rewarming began.Nurse reported that the device had been giving alert 113 (reduced water temp control) again this evening.Last night device was giving same alarm and 500 mls of water was drained.Nurse stated that the device worked fine all day but tonight the device is giving alert 113(reduced water temp control) again, patient temperature was 32.9c, water temperature was 30.8c, flow rate was 3l/min, target temperature was 33c.Mss recommended nurse to change out the device and label this one with alert 113(reduced water temp control) and send this one for repair.Nurse had another device available.Mss explained that nurse needed to empty the pads into this device before changing to the new device.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13641016
• MDR Text Key: 286674557
• Report Number: 1018233-2022-00960
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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