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

Model Number 50000000

Device Problems Insufficient Cooling (1130); Inaccurate Flow Rate (1249); Inadequacy of Device Shape and/or Size (1583); Temperature Problem (3022)

Patient Problems Hypothermia (1915); 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. 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 the patient was above target. The target temperature was 36c. The complainant stated that medium pads were used and there was at least 10 inches of exposed abdomen. No universal pad were available. The patient's temperature was below 36 initially, but increased to 36. 8c. The patient was shivering and jerking so propofol and fentanyl were administered. The water temperature was 18c, the flow rate was 2. 3 lpm. The patient weighed (b)(6). The complainant was informed that the patient weighed more than (b)(6) and would need 4 large pads and 1 universal pad for optimal therapy. The nurse called back after one hour and reported that the patient's temperature was still 33. 8c, water temperature was 10c, and the flow rate was 2. 1 lpm. The pads were switched. Per follow up, after switching to large pads, the patient was able to complete therapy without any issue. The device remained in service.

• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7578902
• MDR Text Key: 110448869
• Report Number: 1018233-2018-02106
• 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

• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Device Lot Number: N/A
• 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: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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: 06/07/2018 Patient Sequence Number: 1