MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 5000-01-03

Device Problem Power Problem (3010)

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

Event Date 01/17/2024

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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse stated that the patient has been on therapy since monday, but they were getting low flow alert in an arctic sun device.Swapped out to a different device and still receiving the same alert.Verified only 2 pads currently connected to device - 1 chest and 1 thigh.Advised they would need to connect all 4 pads even if they were unable to apply to the patient directly.Nurse reconnected third and fourth pads.Noted patient was very small so not all pads were in use.Upon connection of 4th pad the device screen went blank and started beeping.Had nurse power device off and back on.Device did not power on and began beeping again.Verified device was not plugged into a bed and was plugged into a grounded outlet.Powered off and on again with no resolution.Advised to swap to original device and send this one to biomed (b)(6).Nurse connected to original device and reconnected 4 pads.Normothermia targeted temperature (tt) was 36c and started therapy.Device water flow rate (wfr) was stabilized at 2.7 l/m.No errors or alerts.Advised to call back with any additional questions or concerns.Per follow up information received via email on (b)(6) 2024, the device has not been sent in for evaluation.The hospital¿s biomedical engineers could not replicate the issue.They came in to perform calibration on this device last week as it was due.Afterwards, they connected pads and did not have any alarms regarding low flow and also could not replicate issue.Since then, no complaints from nursing staff on unit, so for now seems issue was resolved.Patient swapped to units other arctic sun device.No reported patient negative impact.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The reported event is unconfirmed, dhr review and labeling/packaging review are not required.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 the nurse stated that the patient has been on therapy since monday, but they were getting low flow alert in an arctic sun device.Swapped out to a different device and still receiving the same alert.Verified only 2 pads currently connected to device - 1 chest and 1 thigh.Advised they would need to connect all 4 pads even if they were unable to apply to the patient directly.Nurse reconnected third and fourth pads.Noted patient was very small so not all pads were in use.Upon connection of 4th pad the device screen went blank and started beeping.Had nurse power device off and back on.Device did not power on and began beeping again.Verified device was not plugged into a bed and was plugged into a grounded outlet.Powered off and on again with no resolution.Advised to swap to original device and send this one to biomed ((b)(6)).Nurse connected to original device and reconnected 4 pads.Normothermia targeted temperature (tt) was 36c and started therapy.Device water flow rate (wfr) was stabilized at 2.7 l/m.No errors or alerts.Advised to call back with any additional questions or concerns.Per follow up information received via email on (b)(6)2024, the device has not been sent in for evaluation.The hospital¿s biomedical engineers could not replicate the issue.They came in to perform calibration on this device last week as it was due.Afterwards, they connected pads and did not have any alarms regarding low flow and also could not replicate issue.Since then, no complaints from nursing staff on unit, so for now seems issue was resolved.Patient swapped to units other arctic sun device.No reported patient negative impact.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: 18630187
• MDR Text Key: 334426355
• Report Number: 1018233-2024-00416
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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