MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE; UNKNOWN ARCTIC SUN TEMPERATURE CABLE

Device Problems Unable to Obtain Readings (1516); Device Sensing Problem (2917)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the nurse was not getting a temperature reading from the bedside monitor.There was an esophageal probe in use, which was reading on the arctic sun device with no issue.The temp-out cable was connected to the bedside monitor.Per troubleshooting with ms&s, the nurse was advised to swap out the cable and, if this did not fix the issue, send the device to biomed.Per follow up with the nurse via phone on 06aug2019, the cable was not replaced.They replaced the esophageal probe, but it did not resolve the issue.

Event Description

It was reported that the nurse was not getting a temperature reading from the bedside monitor.There was an esophageal probe in use, which was reading on the arctic sun device with no issue.The temp-out cable was connected to the bedside monitor.Per troubleshooting with ms&s, the nurse was advised to swap out the cable and, if this did not fix the issue, send the device to biomed.Per follow up with nurse via phone on 06aug2019, the cable was not replaced.They replaced the esophageal probe, but it did not resolve the issue.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿power on 1) turn the power on by activating the power switch.2) the control module will automatically go through a brief self-test of the independent safety alarm.3) a new user training module option is available from the start up screen.4) when the self-test is complete, the patient therapy selection screen will appear on the control panel.Fill reservoir 1) fill the reservoir with sterile water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun® temperature management system cleaning solution to the sterile water.4) from the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on the screen.Functional verification perform the following functional verification procedure after initial setup and installation of the control module.1) power on the control module 2) from the patient therapy selection screen, press the hypothermia button to display the hypothermia therapy screen.3) from the hypothermia therapy screen, press the manual control button to open the manual control window.4) use the up and down arrows to set the manual control water target temperature to 40°c and the duration to 30 minutes.5) press the start button to initiate manual control.Allow at least 3 minutes for the system to stabilize.6) monitor the flow rate and water temperature in the system status area on the hypothermia therapy screen.7) verify that the flow rate reaches at least 1.5 liters/minute.8) verify that the water temperature increases to 30°c.9) press the stop button.10) set the manual control water target temperature to 4°c and the duration to 30 minutes.11) press the start button to initiate manual control.12) monitor the flow rate and water temperature in the system status area of the hypothermia therapy screen.Verify that the water temperature drops to 6°c.13) press the stop button to stop manual control 14) press the cancel button to close the manual control window 15) power off the control module." section a through f - the information provided by bd 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 bd.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: UNKNOWN ARCTIC SUN TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8917316
• MDR Text Key: 188351466
• Report Number: 1018233-2019-04917
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1