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

Catalog Number 60000000

Device Problems Insufficient Heating (1287); Use of Device Problem (1670)

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

Event Date 07/13/2023

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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse stated they started therapy last night with arctic sun device.The patient temperature was not reaching target temperature, so the hcp decided to start their rewarm early.The night nurse stopped cooling and started rewarm.Today the patient temperature was still not reaching the target temperature and a different hcp told them to start the cooling phase again which they did.The patient temperature was still not reaching target temperature.The patient temperature are 34.6c, target temperature are 36c, water temperature are 27.7c, flow rate are 2.7lpm, patient weight are 109kg with large pads in place.There was some exposed abdomen and before adding pad they needed to investigate why the water temperature was so low.Event log showed only an alert 112 (return to cooling phase) and early in the morning an alert 50 (patient temperature 1 erratic) and it was in line with the time they swapped from the foley probe to the esophageal probe.Foley back was plugged back into bedside monitor and it was close to the esophageal temp (35c on the foley).The therapy was stopped and enabled manual control at 40c.Water temperature was not increasing.Heater command are 100 percentage, system hours are 63, pump hours are 105.Drained 500ml from right side drainage port and water temperature are increased to 40c.In night time the nurse did not document adding any water to the chart, the fill tube was just hanging on the back of the device so they suspect nurse did.They not sure why no alert 113(reduced wt control).During the therapy the water temperature was jumping around all over the place.They explained water temperature should change gradually and was responding the patient temperature and target temperature.They asked video to see this again.They placed the universal over the exposed abdomen and started cooling again are patient temperature are 34.5c (as/esophageal), target temperature are 36c, water temperature are 38.5c, flow rate are 3lpm.They suggested to check the protocol to see they can take any external interventions (i.E.Warm blankets, increase room temp, cover head/hands/feet).The nurse went for break everything looked good (water temperature warm, patient temperature increasing).

Event Description

It was reported that the nurse stated they started therapy last night with arctic sun device.The patient temperature was not reaching target temperature, so the hcp decided to start their rewarm early.The night nurse stopped cooling and started rewarm.Today the patient temperature was still not reaching the target temperature and a different hcp told them to start the cooling phase again which they did.The patient temperature was still not reaching target temperature.The patient temperature are 34.6c, target temperature are 36c, water temperature are 27.7c, flow rate are 2.7lpm, patient weight are 109kg with large pads in place.There was some exposed abdomen and before adding pad they needed to investigate why the water temperature was so low.Event log showed only an alert 112 (return to cooling phase) and early in the morning an alert 50 (patient temperature 1 erratic) and it was in line with the time they swapped from the foley probe to the esophageal probe.Foley back was plugged back into bedside monitor and it was close to the esophageal temp (35c on the foley).The therapy was stopped and enabled manual control at 40c.Water temperature was not increasing.Heater command are 100 percentage, system hours are 63, pump hours are 105.Drained 500ml from right side drainage port and water temperature are increased to 40c.In night time the nurse did not document adding any water to the chart, the fill tube was just hanging on the back of the device so they suspect nurse did.They not sure why no alert 113(reduced wt control).During the therapy the water temperature was jumping around all over the place.They explained water temperature should change gradually and was responding the patient temperature and target temperature.They asked video to see this again.They placed the universal over the exposed abdomen and started cooling again are patient temperature are 34.5c (as/esophageal), target temperature are 36c, water temperature are 38.5c, flow rate are 3lpm.They suggested to check the protocol to see they can take any external interventions (i.E.Warm blankets, increase room temp, cover head/hands/feet).The nurse went for break everything looked good (water temperature warm, patient temperature increasing).Per follow up information completed via phone follow-up on 02aug2023 for additional information.Transferred to charge nurse who commented there had been too many staff working on this one patient and too many changes had been made to therapy and stated once water had been drained from device, there were no further issues and denied any issues with the probes, stating that staff had swapped them to see if probes were the issue with patient not rewarming.Therapy was complete and device has remained in service.

Manufacturer Narrative

Per additional information received, 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.

• Brand Name: ARCTIC SUN STAT
• 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: 17435926
• MDR Text Key: 320170019
• Report Number: 1018233-2023-05696
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• 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