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

Model Number 50000000

Device Problem Insufficient Heating (1287)

Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2021

Event Type  Injury  

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 hypothermia patient temperature was continuing to drop below target while undergoing therapy on arctic sun device. At beginning of shift, the patient temperature was 32. 8c but now the patient temperature was 31. 8c. The target temperature was 33c, the water temperature was 41. 1c and the flow rate was 2. 7 l/m. There was good pad coverage with no exposed abdomen. Also stated that the patient was not on continuous renal replacement therapy (crrt) and the indicator showing 3 bars trending downward. The patient was on propofol, versed, fentanyl and insulin. The patient was on bair huggers and blankets. Discussed effects of medications on patient temperature and trend indicator. Noted that the arctic sun device appeared to be responding to patient appropriately. Advised to consult medical team to evaluate patient issue. Per follow up via nurse (b)(6) on 01feb2021. Patient was able to complete therapy. Vents and warm blankets also used to warm patient. Medication administered to control movement. The arctic sun device already moved so nurse was unable to provide serial number and no additional information available.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11363086
• MDR Text Key: 233077931
• Report Number: 1018233-2021-00684
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/22/2021 Patient Sequence Number: 1