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

Model Number 50000000E

Device Problem Biocompatibility (2886)

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

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the inquirer wanted to know that they should warm the neonate temperature due to low heart rate and asked if there was any supporting literature.Inquirer raised question was there any literature that support low heart rate parameters while cooling neonates.If the neonate had a heart rate (hr) of 65, should they continue cooling at 33.5 c or increase the temperature.Anything on consideration of medication administrated, electrolyte shifts or other vital sign parameters with a low heart rate.Nurse was not currently with the device and stated that knew how to make changes to the device if needed.Patient temperature was 33.5 c, neonate heart rate (hr) was 65 bpm.Nurse stated blood pressure (bp) was acceptable, no pain, no seizures and o2 saturation was 100 percentage.Patient was on fentanyl drip and ativan pushes.Mss explained to nurse decision regarding changes to temperature due to low heart rate (hr) will have to be determined by medical team.Nurse stated they might decide to decrease fentanyl.Mss reminded the nurse of electrolyte shifts during temperature changes and let nurse knew the request for literature will be sent to our medical affairs team.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined, as the issue was not with the unit.Inquirer raised question was there any literature that supports low heart rate parameters while cooling neonates.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The reported event is unconfirmed, labeling/packaging review is not required.H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that the inquirer wanted to know that they should warm the neonate temperature due to low heart rate and asked if there was any supporting literature.Inquirer raised question was there any literature that support low heart rate parameters while cooling neonates.If the neonate had a heart rate (hr) of 65, should they continue cooling at 33.5 c or increase the temperature.Anything on consideration of medication administrated, electrolyte shifts or other vital sign parameters with a low heart rate.Nurse was not currently with the device and stated that knew how to make changes to the device if needed.Patient temperature was 33.5 c, neonate heart rate (hr) was 65 bpm.Nurse stated blood pressure (bp) was acceptable, no pain, no seizures and o2 saturation was 100 percentage.Patient was on fentanyl drip and ativan pushes.Mss explained to nurse decision regarding changes to temperature due to low heart rate (hr) will have to be determined by medical team.Nurse stated they might decide to decrease fentanyl.Mss reminded the nurse of electrolyte shifts during temperature changes and let nurse knew the request for literature will be sent to our medical affairs team.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12067689
• MDR Text Key: 258644487
• Report Number: 1018233-2021-03806
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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