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

Model Number 50000000E

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2021

Event Type  Injury  

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 patient has dropped below target temperature and water temperature was not rising on arctic sun device.The patient temperature was 31.4c, target temperature was 33c, water temperature was 23.8c and flow rate was 2.1 l/m.The patient was 55kg and had size small pads on.Also stated that four hours left to cool when patient started to drop with 2 bars trending downward.Patient received fentanyl and propofol.Nurse was unsure of any alerts.Mss walked through event log and they have received an alert 113 (reduced water temperature control) 4 times.Nurse noted that they had a power surge.Mss explained alert and accessed diagnostics.The outlet monitor temperature (t1) was 23.7c, the outlet control temperature (t2) was 24c, the inlet temperature (t3) was 24.4c, the chiller temperature (t4) was 11.1c, water flow rate was 2.1 l/m, inlet pressure was -7.0 psi, circulation pump command was 53%, mixing pump command was 0% , heater was 100% , water reservoir level was 5, system hours were 203.2 (checked twice) and pump hours were 1071.0.Noted that device might be overfilled which could cause issues with being able to heat.Nurse noted after power surge, they received alert about adding water.Explained after a power surge to drain pads and check accurate water level.Mss walked nurse through draining water out of right drain port.The user restarted therapy and flow rate increased to stable 3.2 l/m, water temperature increased from 21.5c to 25.2c in about 60 seconds.Also stated water temperature was continuing to increase and trend indicator now only shows one bar trending downward.Mss advised nurse to monitor and make sure water temperature continued to increase.The user would call back if any additional issues or concerns.Per follow up via nurse on (b)(6) 2021, medication administered as per hospital protocol.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was confirmed to be an overfill issue.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.Potential root causes were identified and reviewed.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: ''ifu for filling the reservoir: fill reservoir 1) fill the reservoir with sterile water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun® temperature management system cleaning solution to the sterile water.4) from the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on the screen.'' 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.

Event Description

It was reported that the patient has dropped below target temperature and water temperature was not rising on arctic sun device.The patient temperature was 31.4c, target temperature was 33c, water temperature was 23.8c and flow rate was 2.1 l/m.The patient was 55kg and had size small pads on.Also stated that four hours left to cool when patient started to drop with 2 bars trending downward.Patient received fentanyl and propofol.Nurse was unsure of any alerts.Mss walked through event log and they have received an alert 113 (reduced water temperature control) 4 times.Nurse noted that they had a power surge.Mss explained alert and accessed diagnostics.The outlet monitor temperature (t1) was 23.7c, the outlet control temperature (t2) was 24c, the inlet temperature (t3) was 24.4c, the chiller temperature (t4) was 11.1c, water flow rate was 2.1 l/m, inlet pressure was -7.0 psi, circulation pump command was 53%, mixing pump command was 0% , heater was 100% , water reservoir level was 5, system hours were 203.2 (checked twice) and pump hours were 1071.0.Noted that device might be overfilled which could cause issues with being able to heat.Nurse noted after power surge, they received alert about adding water.Explained after a power surge to drain pads and check accurate water level.Mss walked nurse through draining water out of right drain port.The user restarted therapy and flow rate increased to stable 3.2 l/m, water temperature increased from 21.5c to 25.2c in about 60 seconds.Also stated water temperature was continuing to increase and trend indicator now only shows one bar trending downward.Mss advised nurse to monitor and make sure water temperature continued to increase.The user would call back if any additional issues or concerns.Per follow up via nurse on 30apr2021, medication administered as per hospital protocol.

• 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: 11826369
• MDR Text Key: 250665464
• Report Number: 1018233-2021-02805
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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): Required Intervention
• Patient Weight: 55 KG