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 08/17/2022

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 was getting an alert 113 (reduced wt water temperature control).Patient temperature was 31.4c, target temperature was 34c, flow rate was 2.9lpm, water temperature was 26.4c, and water level was 4.Nurse mentioned the device needed water and they filled the machine.The device then alerted 113 (reduced water temperature control).Nurse drained 500ml of water from right drain port and placed device in manual control at 40c but it was very slow to heat water.System hours were 7877, pump hours were 7423 and heater pump command (hpc) was 100percentage.Mss checked salesforce records and they told them to send this device to biomed for heater to be checked out on (b)(6) 2022.As per follow-up via phone on (b)(6) 2022, it was stated that patient completed therapy on a different device with no issues.The nurse sent device down to biomed and had no details or information on status of the device.As per communication with biomed and tech support on (b)(6) 2022, biomed was sending the device in for 2k preventive maintenance service and repair.As per sample evaluation results received on (b)(6) 2022, it was noted that the hot side connection between the power inlet module and the main voltage circuit card shows signs of electrical overstress.Per patient data reviewed, there was a drop off in flow rate during therapy due to a faulty circulation pump.It was also noted that the double bend tube to the manifold and the chiller evaporator outlet l tube were expanded.It was stated that the tank seals were lifted.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.H11: section a through f - the information provided by bd represents all of 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 was getting an alert 113 (reduced wt water temperature control).Patient temperature was 31.4c, target temperature was 34c, flow rate was 2.9lpm, water temperature was 26.4c, and water level was 4.Nurse mentioned the device needed water and they filled the machine.The device then alerted 113 (reduced water temperature control).Nurse drained 500ml of water from right drain port and placed device in manual control at 40c but it was very slow to heat water.System hours were 7877, pump hours were 7423 and heater pump command (hpc) was 100percentage.Mss checked salesforce records and they told them to send this device to biomed for heater to be checked out on 14mar2022.As per follow-up via phone on (b)(6)2022, it was stated that patient completed therapy on a different device with no issues.The nurse sent device down to biomed and had no details or information on status of the device.As per communication with biomed and tech support on 18april2022, biomed was sending the device in for 2k preventive maintenance service and repair.As per sample evaluation results received on 17aug2022, it was noted that the hot side connection between the power inlet module and the main voltage circuit card shows signs of electrical overstress.Per patient data reviewed, there was a drop off in flow rate during therapy due to a faulty circulation pump.It was also noted that the double bend tube to the manifold and the chiller evaporator outlet l tube were expanded.It was stated that the tank seals were lifted.

• 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: 15310430
• MDR Text Key: 298775416
• Report Number: 1018233-2022-06723
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• 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