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

Catalog Number 60000000

Device Problems Inaccurate Flow Rate (1249); Use of Device Problem (1670)

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

Event Date 08/17/2023

Event Type  malfunction  

Event Description

It was reported that the nurse stated that they had a baby currently cooling on the arctic sun device.When they started the shift, they noticed the flow rate was about 0.8-0.9 l/min.Nurse stated they had tried troubleshooting the pad a few times and was able to get the flow rate above 1.1 l/min.Eventually the flow rate was back to 0.9 l/min and it said air leak below the flow rate and they tried straightening the tubing and disconnecting and reconnecting the pad and eventually thought they heard a water bubbling sound at the clamp.Nurse stated that the clamps where difficult to take off and thought might be it was damaged at some point and ended up replacing the pad with a brand-new pad.The new pad was also reading 0.9 l/min.Nurse thought the flow rate was supposed to be above 1.1 l/min.Informed nurse a normal water flow rate (wfr) for the neonatal pads was typically around 1.1 l/min.Explained because of their smaller surface area, they were not able to always achieve this.They tend to see the flow rate above 0.8 l/min, and this was usually adequate for therapy.Nurse confirmed the current water flow rate (wfr) was 0.9-1 l/min.Nurse stated that they see bubbles in the prongs and did not know if this was normal and worse when they lift the blue tubing.Informed nurse they might see a few bubbles, however there should not be a lot of bubbles in the clamps.While on the phone, the water flow rate (wfr) dropped to 0.8 l/min and said low air leak again.Had nurse pause therapy and empty the pads.Informed nurse to remove the clamp, they would need to squeeze the clamp, push into the fluid delivery line (fdl) and then pull off the fluid delivery line (fdl).Nurse confirmed this was much easier and they were pulling them straight off before.Had nurse reconnect the pad holding only the blue tubing and not the clear clamp piece.Nurse resumed therapy, water flow rate (wfr) was settled at 0.9 l/min.System diagnostics showed that the inlet pressure (ip) was -7, circulation pump command (cpc) was 28 percentage, system hours were 1,743 and pump hours were 1,619.Nurse stated they would watch the flow rate for now and monitor the patient temperature, they did not want to pause therapy for too long.Informed nurse if the water flow rate (wfr) was dropped to 0.7 l/min and did not recover, call them back and do further troubleshooting.

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

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 the nurse stated that they had a baby currently cooling on the arctic sun device.When they started the shift, they noticed the flow rate was about 0.8-0.9 l/min.Nurse stated they had tried troubleshooting the pad a few times and was able to get the flow rate above 1.1 l/min.Eventually the flow rate was back to 0.9 l/min and it said air leak below the flow rate and they tried straightening the tubing and disconnecting and reconnecting the pad and eventually thought they heard a water bubbling sound at the clamp.Nurse stated that the clamps where difficult to take off and thought might be it was damaged at some point and ended up replacing the pad with a brand-new pad.The new pad was also reading 0.9 l/min.Nurse thought the flow rate was supposed to be above 1.1 l/min.Informed nurse a normal water flow rate (wfr) for the neonatal pads was typically around 1.1 l/min.Explained because of their smaller surface area, they were not able to always achieve this.They tend to see the flow rate above 0.8 l/min, and this was usually adequate for therapy.Nurse confirmed the current water flow rate (wfr) was 0.9-1 l/min.Nurse stated that they see bubbles in the prongs and did not know if this was normal and worse when they lift the blue tubing.Informed nurse they might see a few bubbles, however there should not be a lot of bubbles in the clamps.While on the phone, the water flow rate (wfr) dropped to 0.8 l/min and said low air leak again.Had nurse pause therapy and empty the pads.Informed nurse to remove the clamp, they would need to squeeze the clamp, push into the fluid delivery line (fdl) and then pull off the fluid delivery line (fdl).Nurse confirmed this was much easier and they were pulling them straight off before.Had nurse reconnect the pad holding only the blue tubing and not the clear clamp piece.Nurse resumed therapy, water flow rate (wfr) was settled at 0.9 l/min.System diagnostics showed that the inlet pressure (ip) was -7, circulation pump command (cpc) was 28 percentage, system hours were 1,743 and pump hours were 1,619.Nurse stated they would watch the flow rate for now and monitor the patient temperature, they did not want to pause therapy for too long.Informed nurse if the water flow rate (wfr) was dropped to 0.7 l/min and did not recover, call them back and do further troubleshooting.Per follow up information received via ibc on 20sep2023, it was reported that the patient was a male between 48-72 hours old.Nurse stated that was instructed by mis to unplug and replug the pads in.That did not work so they changed the pads and then discovered air bubbles in the tube, so they were then instructed to drain the reservoir and refill it.These steps resolved the issues.The device did not go to biomed.No impact to the patient and therapy was completed.

Event Description

It was reported that the nurse stated that they had a baby currently cooling on the arctic sun device.When they started the shift, they noticed the flow rate was about 0.8-0.9 l/min.Nurse stated they had tried troubleshooting the pad a few times and was able to get the flow rate above 1.1 l/min.Eventually the flow rate was back to 0.9 l/min and it said air leak below the flow rate and they tried straightening the tubing and disconnecting and reconnecting the pad and eventually thought they heard a water bubbling sound at the clamp.Nurse stated that the clamps where difficult to take off and thought might be it was damaged at some point and ended up replacing the pad with a brand-new pad.The new pad was also reading 0.9 l/min.Nurse thought the flow rate was supposed to be above 1.1 l/min.Informed nurse a normal water flow rate (wfr) for the neonatal pads was typically around 1.1 l/min.Explained because of their smaller surface area, they were not able to always achieve this.They tend to see the flow rate above 0.8 l/min, and this was usually adequate for therapy.Nurse confirmed the current water flow rate (wfr) was 0.9-1 l/min.Nurse stated that they see bubbles in the prongs and did not know if this was normal and worse when they lift the blue tubing.Informed nurse they might see a few bubbles, however there should not be a lot of bubbles in the clamps.While on the phone, the water flow rate (wfr) dropped to 0.8 l/min and said low air leak again.Had nurse pause therapy and empty the pads.Informed nurse to remove the clamp, they would need to squeeze the clamp, push into the fluid delivery line (fdl) and then pull off the fluid delivery line (fdl).Nurse confirmed this was much easier and they were pulling them straight off before.Had nurse reconnect the pad holding only the blue tubing and not the clear clamp piece.Nurse resumed therapy, water flow rate (wfr) was settled at 0.9 l/min.System diagnostics showed that the inlet pressure (ip) was -7, circulation pump command (cpc) was 28 percentage, system hours were 1,743 and pump hours were 1,619.Nurse stated they would watch the flow rate for now and monitor the patient temperature, they did not want to pause therapy for too long.Informed nurse if the water flow rate (wfr) was dropped to 0.7 l/min and did not recover, call them back and do further troubleshooting.Per follow up information received via ibc on 20sep2023, it was reported that the patient was a male between 48-72 hours old.Nurse stated that was instructed by mis to unplug and replug the pads in.That did not work so they changed the pads and then discovered air bubbles in the tube, so they were then instructed to drain the reservoir and refill it.These steps resolved the issues.The device did not go to biomed.No impact to the patient and therapy was completed.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to user not filling the device correctly.They started the shift, they noticed the flow rate was about 0.8-0.9 l/min.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "fill reservoir approximately four liters of sterile water will be required to fill the reservoir at initial installation.Fill the reservoir with sterile water only.When filling the control module during initial installation or when completely empty, add one vial of arctic sun¿ temperature management system arctic sun cleaning solution to the sterile water.It is recommended to add the vial when filling with the second liter of sterile water.1) from the patient therapy selection screen, select the button next to either normothermia or hypothermia under the new patient heading.Select any pad type to continue.2) from the hypothermia or normothermia therapy screen, press the fill reservoir button.3) the fill reservoir screen will appear.Follow the directions on the screen.4) the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.5) when the fill reservoir process is complete, the screen will close.6) to stop the process early, press the stop button.Note: if the filling cycle is stopped prior to completion, the reservoir will not be full and may requiring filling after fewer patient therapies have been performed.7) press the cancel button to close the screen." 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.

• 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: 17682587
• MDR Text Key: 322646080
• Report Number: 1018233-2023-06538
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• 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,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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