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

Model Number 50000000E

Device Problems Break (1069); Insufficient Cooling (1130); No Display/Image (1183); Display or Visual Feedback Problem (1184); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.

Event Description

It was reported that the arctic sun device displayed an alert 113 ( reduced water temperature control) when the patient was cooling under hypothermia phase. The patient temperature was 33. 6c and the water temperature was 30. 3c. The flow rate was 2. 8lpm. In manual control, the outlet monitor temperature and the outlet control temperature were remained at 30. 3c and the chiller temperature was 3. 9c. Mss advised the nurse to change out the device since it could not deliver cold water. The nurse changed devices and the second device would not display the patient's temperature and displayed an alert 14 ( patient temperature 1 probe out of range). The nurse replaced the cable with the cable from the first device. The patient's temperature then displayed. The therapy was restarted then the flow rate was stabilized at 3. 1 l/min. The cable was labelled as broken and also the arctic sun device was labelled with alert 113 not cooling and sent to the biomed department. Per follow up on (b)(6) 2020, nurse stated the device was sent to biomed and the patient was able to complete therapy on the second device. Unknown about the cable status.

• Brand Name: ARCTIC SUN 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: 10151339
• MDR Text Key: 195397026
• Report Number: 1018233-2020-03790
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/13/2020
• Is this an Adverse Event Report?: No
• 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: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse