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

Model Number 50000000

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Temperature Problem (3022)

Patient Problems Cardiac Arrest (1762); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.

Event Description

It was reported that there was suboptimal flow and the water temperature was fluctuating. The nurse reported that the patient was (b)(6) year old and post cardiac arrest post seizure. The patient's temperature was in the 38c range, the target temperature was 36c, and the water temperature was 29c. She stated she was seeing many air bubbles in the line. Per troubleshooting, it was explained that if the device was not alarming air bubbles, then it was not a concern. The nurse stated she was seeing the water temperature fluctuate. During the call the nurse reported that there was an alarm for suboptimal flow. The flow rate was 1. 5 l/min. She was advised to stop therapy, empty the pads, disconnect and reconnect the pads using the proper technique. The flow rate was in the 3 l/min range. The nurse checked the patient's temperature with an alternate source and she noted that it correlated. It was explained that the flow rate was optimal, the temperatures correlated and the water temperature was decreasing in order to bring down the patients temperature. Per additional information, therapy was stopped and the patient was taken off of the device. Per additional information, the nurse stated that therapy was stopped and the patient was taken off of the device because the patient was not cooling. She said the patient's temperature rose to 102f, so they ended up packing the patient with ice and wrapped them in a cooling blanket.

• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7481356
• MDR Text Key: 107517210
• Report Number: 1018233-2018-01444
• 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: 06/20/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/02/2018
• 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: 06/18/2018
• 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