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

Model Number 50000000E

Device Problem Nonstandard Device (1420)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that the patient started cooling on the arctic sun device but was still at 37.4c.The target was 35c, water was at 31.3c, t4 (chiller temperature) was 4c, mixing pump command was 100 percentage, system hours were 1467 and pump hours were 1334.Mss advised to send device to biomed labeled alert 113 (reduced water temperature control, not cooling).This was their only device.Mss asked to use another device means of cooling.The device was sent to biomed on (b)(6) 2022.Biomed requested a 2000-hour preventive maintenance on this device.Per follow up information received via phone on 25oct2022, the device was sent to biomed, and they did not report any device malfunctions.Biomed approved the estimate, the device was coming in for service, waiting on shipment.Per follow up information received via phone on 31oct2022, no reported injuries during the reported event.The patient was moved off the arctic sun and completed therapy using a different cooling method.Per sample evaluation results received on 08dec2022, it was stated that the root cause of the reported issue was a failed mixing pump.It was determined that the device did not cool during the decontamination process.It was also stated that patient data dated (b)(6) 2022 contained confirmed alert 113(reduced water temperature control).It was noted that installed a test mixing pump to cool.It was also noted that the systems receiving low-flow alerts, flow through shunts.The double-bend tube and the chiller evaporator outlet tube were found expanded during servicing.Tank seals were found degraded and lifted from the tank.It was also noted that all double bend tubes, chiller evaporator outlet tubes, and tank seals were replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that this mdr event is not reportable.

Event Description

It was reported that the patient started cooling on the arctic sun device but was still at 37.4c.The target was 35c, water was at 31.3c, t4 (chiller temperature) was 4c, mixing pump command was 100 percentage, system hours were 1467 and pump hours were 1334.Mss advised to send device to biomed labeled alert 113 (reduced water temperature control, not cooling).This was their only device.Mss asked to use another device means of cooling.The device was sent to biomed on 24oct2022.Biomed requested a 2000-hour preventive maintenance on this device.Per follow up information received via phone on 25oct2022, the device was sent to biomed, and they did not report any device malfunctions.Biomed approved the estimate, the device was coming in for service, waiting on shipment.Per follow up information received via phone on 31oct2022, no reported injuries during the reported event.The patient was moved off the arctic sun and completed therapy using a different cooling method.Per sample evaluation results received on 08dec2022, it was stated that the root cause of the reported issue was a failed mixing pump.It was determined that the device did not cool during the decontamination process.It was also stated that patient data dated 22oct2022 contained confirmed alert 113(reduced water temperature control).It was noted that installed a test mixing pump to cool.It was also noted that the systems receiving low-flow alerts, flow through shunts.The double-bend tube and the chiller evaporator outlet tube were found expanded during servicing.Tank seals were found degraded and lifted from the tank.It was also noted that all double bend tubes, chiller evaporator outlet tubes, and tank seals were replaced.

• 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: 16052038
• MDR Text Key: 308478629
• Report Number: 1018233-2022-09842
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 03/03/2023

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/04/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• 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