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

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration in Body Temperature (4568)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the arctic sun device was getting low flow (alert 02) alert.The patient temperature was 34.3c and the target temperature was 33c.The water temperature was 11c, the flow rate was 1.5 lpm and the nurse was unsure whether small or medium pads were in place.It was also confirmed that patient went to computed tomography (ct) with arctic gel pads in place and there was no flow issues prior to that.It was also reported that the inlet pressure was -7.1psi, the system hours were 2374 and the pump hours were 2276.The gel pads were then disconnected and reconnected using proper technique after which the flow rate increased to 2.3 lpm.Ms&s advised the complainant that it might be necessary to change one or more pads if they continued to get low flow alerts.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.The device was not returned.

Event Description

It was reported that the arctic sun device was getting low flow (alert 02) alert.The patient temperature was 34.3c and the the target temperature was 33c.The water temperature was 11c, the flow rate was 1.5 lpm and the nurse was unsure whether small or medium pads were in place.It was also confirmed that patient went to computed tomography (ct) with arctic gel pads in place and there was no flow issues prior to that.It was also reported that the inlet pressure was -7.1psi, the system hours were 2374 and the pump hours were 2276.The gel pads were then disconnected and reconnected using proper technique after which the flow rate increased to 2.3 lpm.Ms&s advised the complainant that it might be necessary to change one or more pads if they continued to get low flow alerts.Per follow-up on 07jan2021 nurse stated that all issues were resolved during troubleshooting.Patient completed therapy with no further issues.

• 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
• MDR Report Key: 10986962
• MDR Text Key: 221297100
• Report Number: 1018233-2020-21584
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other