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

Model Number 50000000E

Device Problems Insufficient Cooling (1130); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)

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 device was not cooling a hypothermia patient. Therapy began at 9:30am. Target temperature was 34c, water temperature was 5c, and the flow rate was good. The nurse stated the patient's temperature only got to 35. 6 since starting therapy. The patient was started on a propafol drip at 2 pm. The patient weighed (b)(6) kg and had 4 pads in place. Ms&s informed the nurse that the device appeared to be working properly and the issue appeared to be patient related. Ms&s discussed causes of heat generation and counter warming, recommended a universal pad be added to the patients lower abdomen, and discussed the importance of following medication protocol for heat generation. The nurse stated she would apply the bair hugger, add a universal pad and call back in an hour with an update. Approximately 1 hour later, the nurse applied that pad and stated the patient temperature was 35. 2c, water temperature was 4. 9c and the flow rate was 2. 6.

• Brand Name: ARCTICSUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9410822
• MDR Text Key: 178587872
• Report Number: 1018233-2019-07695
• 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: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• 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: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: 12/04/2019 Patient Sequence Number: 1