MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS UNKNOWN ARCTIC GEL PADS

Catalog Number UNKNOWN

Device Problems Insufficient Flow or Under Infusion (2182); Device Sensing Problem (2917)

Patient Problem 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.

Event Description

It was reported that the normothermia patient was on arctic sun device. They were getting a low flow alert (alert 02). The pads may be on due to be changed. The nurse attempted to empty the pads, but received alert 07 (empty pads cycle not complete). Disconnected pads and placed device in manual mode. Fluid delivery line showed flow rate of 1. 7lpm, inlet pressure of 7. 0psi, circulation pump command 45%. Left chest flow rate was 1. 6lpm, inlet pressure was 7. 1psi, circulation pump command 45%. Right chest flow rate of 1. 7lpm, inlet pressure -7. 1psi, circulation pump command 45%. Left thigh flow rate of 2. 2lpm, inlet pressure -7. 3psi, circulation pump command 52%. Right thigh: flow rate 2. 1lpm, inlet pressure -7. 0psi, circulation pump command 59%. System hours 3794. Pump hours 3301. Placed device back on automatic mode. Flow 2. 1lpm. While testing the flow of the device it gave a low patient temperature alert. Patient temperature read 15. 3c. The foley probe was on use. Nurse adjusted the probe and now temperature reads 36. 2c. Explained that the probe or temperature in cable needs to be changed should the patient's temperature drop like that again. Nurse stated that the device accidentally came unplugged from the wall earlier and thought that was when the alerts began.

• Brand Name: ARCTIC GEL PADS
• Type of Device: UNKNOWN ARCTIC 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: 10465121
• MDR Text Key: 227880403
• Report Number: 1018233-2020-05501
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial