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

Model Number 50000000

Device Problems Insufficient Cooling (1130); Failure to Pump (1502)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

It was reported that normothermia patient was on the arctic sun device and nurse stated the device was alarming but did not believe the device was functioning properly.Patient temperature was 37.6c, target temperature was 37c, water temperature was 32c and flow rate was 2.4lpm.Event log showed multiple alert 113 (reduced water temperature control) and alert 116 (patient temperature 1 change not detected).Chiller temperature (t4) was 4.3c and mixing pump command was 100 percent.Mss explained what alert 113 meant and advised that the device was unable to make water to the desired temperature.Mss also recommended the nurse to change the device and told them to empty the pads into this device and send to the clinical engineering department for repair labeled alert 113 (reduced water temperature control).Per additional information received on 07-mar-22, biomed stated they would order and replace the mixing pump onsite.Per follow up information received on 08-mar-2022, biomed would order a mixing pump and fix it onsite, the device was being used on a patient during the reported event with no reported injury.It was unknown if the patient completed therapy on same device.Per follow up information received on 11-mar-2022, the mixing pump was one of the components that made cold water for therapy, so as a result of the pump failure it caused an inability to cool.There were no other failures reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

• 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: 13930024
• MDR Text Key: 288051213
• Report Number: 1018233-2022-01665
• 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: 08/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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