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

Model Number 50000000

Device Problems Failure to Pump (1502); Pumping Problem (3016)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that the patient was cooling for 4 hours on arctic sun device, but device was not cooling the patient.Nurse stated that patient temperature was 39c, target temperature was 37c, water temperature was 37c.Nurse swapped the patient to another arctic sun device.Device alerted to fill.They attempted to fill, but it would not suck up water.No pads were connected.Device then had an alarm 47 (control panel communication).Nurse tried to power off and then to switch it on but there was no change.Nurse swapped patient out to third device and patient was actively cooling.Mss asked the nurse to power on arctic sun device and to place in manual control at 4c.System diagnostics showed outlet monitor temperature (t1) was 34.4c, outlet control temperature (t2) was 34.9c, inlet temperature (t3) was 36.3c, chiller temperature (t4) was 6c, water flow rate was 1.6 l/m, inlet pressure was -7psi, circulation pup command was 49 percent, mixing pump command was 0 percent, heater was 25 percent, water reservoir level was 4, system hours were 6356.1 and pump hours were 5603.9.Water temperature did not drop below 30c and then increased to 36.5c.Mss advised nurse to send arctic sun device to biomed.Mss also advised the nurse that arctic sun device would need to go to biomed for evaluation of alarm 47 (control panel communication) and device would not fill.Per additional information received on (b)(6) 2022, biomed had sent the data files which showed that the mixing pump had failed.Biomed stated would order and replace the pump onsite.Per follow-up received via phone on (b)(6) 2022, nurse stated that there were no patient injuries and patient was able to complete therapy on another unknown device.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed mixing pump.Dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Based on the results of the investigation, no additional actions are needed.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Therefore, labeling review was not required.The device was not returned.

Event Description

It was reported that the patient was cooling for 4 hours on arctic sun device, but device was not cooling the patient.Nurse stated that patient temperature was 39c, target temperature was 37c, water temperature was 37c.Nurse swapped the patient to another arctic sun device.Device alerted to fill.They attempted to fill, but it would not suck up water.No pads were connected.Device then had an alarm 47 (control panel communication).Nurse tried to power off and then to switch it on but there was no change.Nurse swapped patient out to third device and patient was actively cooling.Mss asked the nurse to power on arctic sun device and to place in manual control at 4c.System diagnostics showed outlet monitor temperature (t1) was 34.4c, outlet control temperature (t2) was 34.9c, inlet temperature (t3) was 36.3c, chiller temperature (t4) was 6c, water flow rate was 1.6 l/m, inlet pressure was -7psi, circulation pup command was 49 percent, mixing pump command was 0 percent, heater was 25 percent, water reservoir level was 4, system hours were 6356.1 and pump hours were 5603.9.Water temperature did not drop below 30c and then increased to 36.5c.Mss advised nurse to send arctic sun device to biomed.Mss also advised the nurse that arctic sun device would need to go to biomed for evaluation of alarm 47 (control panel communication) and device would not fill.Per additional information received on 09-aug-2022, biomed had sent the data files which showed that the mixing pump had failed.Biomed stated would order and replace the pump onsite.Per follow-up received via phone on 10-aug-2022, nurse stated that there were no patient injuries and patient was able to complete therapy on another unknown 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15300294
• MDR Text Key: 305541400
• Report Number: 1018233-2022-06671
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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