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

Device Problems Use of Device Problem (1670); Device Sensing Problem (2917)

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

Event Date 08/26/2023

Event Type  malfunction  

Event Description

It was reported that the nurse had an issue with arctic sun device off and on all day while cooling per day shift.Targeted temperature (tt) was 33.5c and water temperature (wt) had been going up and down.Even reached 40.2c despite patient temperature (pt) was being 36.1c.They told to remove patient from therapy all together.Per event log device had been alarming 15 (unable to obtain a stable patient temperature), 50 (patient temperature 1 erratic) and 14 (patient temperature 1 probe out of range) all throughout patient therapy.Patient had esophageal probe in place and placement was verified via xray.Explained without patient still being on the device it was difficult to know the exact issue, but it sounds like the temperature cable needs to be replaced.Explained if they had called in while patient was still on device, they would had them check cable connections to probe and device, plug probe into alternate source to verify probe worked and then replace temperature cable.Advised to consult biomed for new cable.

Manufacturer Narrative

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

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.H11: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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse had an issue with arctic sun device off and on all day while cooling per day shift.Targeted temperature (tt) was 33.5c and water temperature (wt) had been going up and down.Even reached 40.2c despite patient temperature (pt) was being 36.1c.They told to remove patient from therapy all together.Per event log device had been alarming 15 (unable to obtain a stable patient temperature), 50 (patient temperature 1 erratic) and 14 (patient temperature 1 probe out of range) all throughout patient therapy.Patient had esophageal probe in place and placement was verified via xray.Explained without patient still being on the device it was difficult to know the exact issue, but it sounds like the temperature cable needs to be replaced.Explained if they had called in while patient was still on device, they would had them check cable connections to probe and device, plug probe into alternate source to verify probe worked and then replace temperature cable.Advised to consult biomed for new cable.Per customer via phone on 03oct2023, it was reported that the baby was a 3-day old male.Therapy was completed and there was no impact to the patient.Troubleshooting was completed with medical information services (mis) and it was discovered that the connector or temperature probe was not connected properly.After properly connecting the connector, the issue was resolved.The device did not go to biomed.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17763772
• MDR Text Key: 323766964
• Report Number: 1018233-2023-06824
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 03/02/2024
• 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
• Patient Age: 3 DA
• Patient Sex: Male