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

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

It was reported that patient temperature was displayed on the arctic sun device during cooling and rewarming.The patient was now maintaining normothermia and the temperature stopped reading.It was just showing dashes in the temperature reading.User changed the foley probe and it still read dashes, so they changed the device.The new device also would not display the temperature.The temperature from the foley probe did read on their bedside monitor.Initially the temperature in cable was in temperature port 2, but the temperature still did not read when moved to temperature port 1.The user got the cable from the first device, and still no temperature was reading.The user would order a new temperature cable and monitor the patient temperature and add a bair hugger if needed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed temperature cable.It was just showing dashes in the temperature reading.Per follow up, nurse stated that there was no patient injury and patient was able to complete therapy.The device and components were sent to biomed for evaluation.Nurse also stated that device was working and in use.After that biomed stated that the device and temperature cable were returned but it was the temperature cable that was not working, so they ordered a new temperature cable which corrected the issue, the device had no issues and was in use.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (temperature cable) product ifus were found to be adequate based on past reviews.Correction: f,h h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that patient temperature was displayed on the arctic sun device during cooling and rewarming.The patient was now maintaining normothermia and the temperature stopped reading.It was just showing dashes in the temperature reading.User changed the foley probe and it still read dashes, so they changed the device.The new device also would not display the temperature.The temperature from the foley probe did read on their bedside monitor.Initially the temperature in cable was in temperature port 2, but the temperature still did not read when moved to temperature port 1.The user got the cable from the first device, and still no temperature was reading.The user would order a new temperature cable and monitor the patient temperature and add a bair hugger if needed.Per follow up information received on 06jan2022, nurse stated that there was no patient injury and patient was able to complete therapy.The device and components were sent to biomed for evaluation.Nurse also stated that device was working and in use.After that biomed stated that the device and temperature cable were returned but it was the temperature cable that was not working, so they ordered a new temperature cable which corrected the issue, the device had no issues and was in use.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: ARCTIC SUN TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13178265
• MDR Text Key: 283395645
• Report Number: 1018233-2021-08711
• Device Sequence Number: 1
• Product Code: DWJ
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other