MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTICSUN GEL PADS

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249)

Patient Problems Alteration In Body Temperature (2682); 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 arctic sun device was displaying an extended period of cold water temp alarm. The water temperature was between 4-9c, the target temperature was 37c, and the patient temperature was 37c. The flow rate was marginal to good at 2lpm - 2. 8lpm. The patient was on dialysis, and was administered tylenol, mag, buspar and antibiotics. Per troubleshooting, it was explained that the patient's heat generation from shivering could contribute to the issue, and that the facility needed to be diligent with skin assessments. Additional information was received from the facility on the 11apr2019, that the patient was able to complete therapy with the same set of pads.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTICSUN GEL PADS
• 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: 8560449
• MDR Text Key: 143414136
• Report Number: 1018233-2019-02202
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/29/2019 Patient Sequence Number: 1