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

Model Number 50000000

Device Problems Insufficient Cooling (1130); Pumping Problem (3016)

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

Event Date 05/24/2022

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.

Event Description

It was reported that the nurse noted the patient temperature was 39.8c on the arctic sun device, but the target temperature was 37c, water temperature was 21.6c, flow rate was 1.8lpm and large pads were used.The nurse denied any alerts or alarms, however when mss guided nurse to the event log alert 113 (reduced water temperature control) was in the recent history.The nurse stated that they have already changed machines and decreased the target temperature to 33c.The second device would not give them a flow rate.Mss guided to system diagnostics and noted that t4 (chiller temperature) was cold (4c) while the mixing pump command was 100percentage, system hours were 8361 and pump hours were 6826.Mss explained this one needed to go to biomed, but they could troubleshoot the device with no flow to see if they could get it running.They could also test the pads to see if one or more of them was leaking air.The nurse was elected not to do this and to use a cooling blanket on the patient instead and nurse would send both the device to biomed.Per follow up information received via phone on 02jun2022, tech support reviewed data files and showed a failed mixing pump.Biomed stated they would repair onsite and no patient injury was reported.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to a faulty mixing pump.The nurse noted the patient temperature was 39.8c on the arctic sun device, but the target temperature was 37c.Water temperature was 21.6c, flow rate was 1.8lpm and large pads were used.The nurse denied any alerts or alarms, however when mss guided nurse to the event log alert 113 (reduced water temperature control) was in the recent history.The nurse stated that they have already changed machines and decreased the target temperature to 33c.Mss guided to system diagnostics and noted that t4 (chiller temperature) was cold (4c) while the mixing pump command was 100percentage, system hours were 8361 and pump hours were 6826.Mss explained this one needed to go to biomed, but they could troubleshoot the device with no flow to see if they could get it running.They could also test the pads to see if one or more of them was leaking air.The nurse was elected not to do this and to use a cooling blanket on the patient instead and nurse would send both the device to biomed.Per follow up information received, tech support reviewed data files and showed a failed mixing pump.Biomed stated they would repair onsite.No patient injury was reported.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 dhr is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.The labelling review is not required since the reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.

Event Description

It was reported that the nurse noted the patient temperature was 39.8c on the arctic sun device, but the target temperature was 37c, water temperature was 21.6c, flow rate was 1.8lpm and large pads were used.The nurse denied any alerts or alarms, however when mss guided nurse to the event log alert 113 (reduced water temperature control) was in the recent history.The nurse stated that they have already changed machines and decreased the target temperature to 33c.The second device would not give them a flow rate.Mss guided to system diagnostics and noted that t4 (chiller temperature) was cold (4c) while the mixing pump command was 100percentage, system hours were 8361 and pump hours were 6826.Mss explained this one needed to go to biomed, but they could troubleshoot the device with no flow to see if they could get it running.They could also test the pads to see if one or more of them was leaking air.The nurse was elected not to do this and to use a cooling blanket on the patient instead and nurse would send both the device to biomed.Per follow up information received via phone on 02jun2022, tech support reviewed data files and showed a failed mixing pump.Biomed stated they would repair onsite and no patient injury was reported.

• 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: 14682470
• MDR Text Key: 293930815
• Report Number: 1018233-2022-04581
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/04/2022
• 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