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

Model Number 50000000

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Infusion or Flow Problem (2964); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

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 evaluated by a biomedical technician at the complainant's facility.

Event Description

It was reported that the arcticsun device was getting a low flow alert (alert 02) during therapy. The patient's temperature of 32. 7c was below the target temperature of 33. 5c. The flow rate was reading 0. 0l/min. No water was seen flowing through the pad connector sites. Per troubleshooting with ms&s, the event log showed the alert 02 as well as an alert 113 (reduced water temperature control). The nurse stated that the patient started therapy in the emergency department and was transferred to the intensive care unit with the device. The nurse tried disconnecting and reconnecting the pads with no change in flow rate. The nurse was then instructed to take off the fluid delivery line and run diagnostics. The flow rate read 1. 9-2. 2l/min, inlet pressure was in the -12psi range, and the circulation pump command was in the 40% range. Reconnection of the fluid delivery line yielded no change in flow rate. The nurse had drained 400cc of water from the device to test the heater, but the heater could not be tested due to the low flow. Additional information was received from the facility on 22may2019, that the device was swapped and the second device gave the same alerts. They did additional troubleshooting on both devices and the patient was placed back on the first device. The second device was sent to the biomed, and the patient was continuing therapy successfully on the first device with the same set of pads with no further issue. Additional information was received via voice message from the biomed on 23may2019 stating that the second device was found to be low on water. After refilling, the device functioned normally and was placed back in service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTICSUN 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: 8683094
• MDR Text Key: 148311610
• Report Number: 1018233-2019-02999
• Device Sequence Number: 1
• Product Code: DWJ
• 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

• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• 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: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse