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

Device Problems Use of Device Problem (1670); Overfill (2404); Device Displays Incorrect Message (2591); 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 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 cooling and the device displayed an alert 113. The patient's temperature was 33. 5c, the target temperature was 33c, and the water temperature was 28. 5c. Per troubleshooting, the nurse explained that the water temperature was not being monitored. She was advised to take have the device taken out of service because it wasn't able to maintain temperature and was no longer safe to use. The nurse wasn't sure if they had another device. It was reported that the biomed received the device and needed assistance troubleshooting. Per troubleshooting, manual control was enabled and the temperature was set to 4c for 30 minutes. With only the fluid delivery line attached, the flow rate was 1. 8l/min, the inlet pressure was -7psi, the circulation pump was 54%, and temperature 1 and 2 quickly decreased. The temperature was 4. 4c. The water level was 5, so 500 ml were drained from the right drain port. The water temperature was set to 42c. The helpline explained that if there was an alert 113, it could mean there was an issue with the heater, chiller, mixing pump or overfill. The biomed called back and confirmed the device heated to 42c without any issues. The biomed stated they would put the device back into service. It was reported that therapy was resumed and the device displayed a flow rate of 0 l/min. The nurse stated that the screen read 'priming' and then the device switched to 'stopped'. Four pads were in use. Per troubleshooting, the flow rate was 0l/min, the inlet pressure was -0. 8 psi, and the circulation pump was 100%. The pads were emptied and disconnected. The device was placed into manual mode. The flow rate was 1. 7l/min, the inlet pressure was -7. 0psi, and the circulation pump was 60%. The right thigh pad was connected. The flow rate was 0. 8l/min, the inlet pressure was -7. 0psi, and the circulation pump was 38%. The left thigh pad was connected. The flow rate was 1. 5l/min, the inlet pressure was -7. 0psi, and the circulation pump was 54%. The right chest pad was connected. The flow rate was 2. 5l/min, the inlet pressure was -7. 3psi, and the circulation pump was 76%. The left chest pad was connected. The flow rate was 3. 3l/min, the inlet pressure was -7. 2psi, and the circulation pump was 94%. The device was placed back into automatic mode. The flow rate was 3. 3l/min, and therapy resumed. It was later reported that the patient was cooling and the device displayed an alert 113. The patient's temperature was 34. 6c, the target temperature was 34c, the water temperature was 30c, the flow rate was 2. 7l/min, and the trend indicator had one arrow pointing up. Per troubleshooting, temperature 1 was 30c, temperature 2 was 30c, temperature 4 was 4. 1c, the circulation pump was 78%, and the mixing pump command was 100%. The nurse was advised to send the device to the biomed for investigation of the mixing pump. The device was replaced with another unit. The nurse was guided through emptying, disconnecting the pads, and switching to the new device to resume therapy. It was later reported on (b)(6) 2018 from nurse (b)(6), the patient continued therapy on a loaner device. She stated that the device was initially sent to the biomed fro repairs and was sent back to the unit for use. The device gave the same issues and was sent to biomed for further evaluation a loaner device was obtained. A follow up call was received from (b)(6) at the biomed on (b)(6) 2018. He stated that the water temperature could not stay constant for long periods of time and it was determined to be an issue with the mixing pump. He stated the device would be sent back for servicing.

• Brand Name: UNKNOWN ARCTICGEL 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: 7647867
• MDR Text Key: 113034018
• Report Number: 1018233-2018-02477
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• 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: 07/16/2018
• 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