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

Model Number 50000000

Device Problem Nonstandard Device (1420)

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

Event Date 10/03/2022

Event Type  malfunction  

Event Description

It was reported that target temperature was 33c and the patient had been below target temperature at 31-31.8c for hours in the arctic sun device.Nurse confirmed patient temperature was 31.8c, target temperature was 33.0 c, water temperature was 37.9c, flow rate was 2.8lpm, 4 large pads with good coverage.They device had an alert 113 (reduced water temperature control).System diagnostics showed outlet monitor temperature (t1) was 38.8c, outlet control temperature (t2) was 38.4c, inlet temperature (t3) was 37.8c, chiller temperature (t4) was 4.8c, inlet pressure was -2.9psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 94 percent, water reservoir level was 5, system hours were 4361 and pump hours were 3897.Mss asked the nurse to drain 500ml from right drain port.Mss instructed how to put device in manual control to 40c; outlet monitor temperature (t1) was 36.1, inlet pressure was -3.2psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 100 percent.Mss had the device back in automatic mode.Nurse stated that water temperature was 36.5c, flow rate was 2.8lpm, inlet pressure was -3.4psi, circulation pump command was 100 percent, mixing pump command was 0 percent and heater command was 100 percent.Mss advised that this device should go to biomed for possible failing circulation pump.Nurse would look for another device for target temperature management.Device was sent to biomed.Per additional information received on (b)(6)2022, biomed stated that the device was getting alert 113 (reduced water temperature control) and not heating, biomed would like to send in for the 2k hour preventive maintenance.Per follow up information received on (b)(6)2022, there was no patient injury reported.Biomed will be sending the device in for assessment and 2k hour preventive maintenance.Per sample evaluation results received on (b)(6)2022, it was reported that the double bend tube was found expanded during servicing.

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.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.

Event Description

It was reported that target temperature was 33c and the patient had been below target temperature at 31-31.8c for hours in the arctic sun device.Nurse confirmed patient temperature was 31.8c, target temperature was 33.0 c, water temperature was 37.9c, flow rate was 2.8lpm, 4 large pads with good coverage.They device had an alert 113 (reduced water temperature control).System diagnostics showed outlet monitor temperature (t1) was 38.8c, outlet control temperature (t2) was 38.4c, inlet temperature (t3) was 37.8c, chiller temperature (t4) was 4.8c, inlet pressure was -2.9psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 94 percent, water reservoir level was 5, system hours were 4361 and pump hours were 3897.Mss asked the nurse to drain 500ml from right drain port.Mss instructed how to put device in manual control to 40c; outlet monitor temperature (t1) was 36.1, inlet pressure was -3.2psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 100 percent.Mss had the device back in automatic mode.Nurse stated that water temperature was 36.5c, flow rate was 2.8lpm, inlet pressure was -3.4psi, circulation pump command was 100 percent, mixing pump command was 0 percent and heater command was 100 percent.Mss advised that this device should go to biomed for possible failing circulation pump.Nurse would look for another device for target temperature management.Device was sent to biomed.Per additional information received on 07sep2022, biomed stated that the device was getting alert 113 (reduced water temperature control) and not heating, biomed would like to send in for the 2k hour preventive maintenance.Per follow up information received on 12sep2022, there was no patient injury reported.Biomed will be sending the device in for assessment and 2k hour preventive maintenance.Per sample evaluation results received on 04oct2022, it was reported that the double bend tube was found expanded during servicing.

• 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: 15597322
• MDR Text Key: 306705267
• Report Number: 1018233-2022-07826
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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