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 12/15/2023

Event Type  malfunction  

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.

Event Description

It was reported that they were trying to cool the patient and the first arctic sun device kept alarming 14 (patient temperature 1 probe out of range).They swapped out probes and swapped to different device.The 2nd device ran for about an hour and started alarming 14 (patient temperature 1 probe out of range) as well.The nurse noted that the patient's temperature was fluctuating frequently during the last hour.The verified probe was at patient temperature 1 port.Explained they need to replace the temperature cable that connects to the back of the device and reach out to biomed for replacement.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed temperature in cable.They swapped out probes and swapped to different device.2nd device ran for about an hour and started alarming 14 (patient temperature 1 probe out of range) as well.Nurse noted that the patient temperature was fluctuating frequently during the last hour.A dhr review is not required as the serial number is unknown.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Corrections: b, e, 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 they were trying to cool patient and first arctic sun device kept alarming 14 (patient temperature 1 probe out of range).They swapped out probes and swapped to different device.2nd device ran for about an hour and started alarming 14 (patient temperature 1 probe out of range) as well.Nurse noted that the patient temperature was fluctuating frequently during the last hour.Verified probe was in patient temperature 1 port.Explained they need to replace the temperature cable that connects into the back of the device and reach out to biomed for replacement.Per additional information received via phone on (b)(6) 2024, it was reported that therapy was completed on the patient without any impact.The patient was a baby that was around 6 hours old and weighed less than 10lbs.Was advised by mis to change the probes and cables.It was discovered that the cables were faulty.Once the cables were replaced, the device worked without issues.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: 18426244
• MDR Text Key: 332626308
• Report Number: 1018233-2023-09404
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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: 02/01/2024
• 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 Weight: 5 KG