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

Model Number 50000000L

Device Problem Insufficient Cooling (1130)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the baby's temperature was up to 34.3c and the target temperature was 33.5c on the arctic sun device.The nurse wanted to know whether they would look up the temperatures other than the graph.The water temperature was 10c, the trend had one arrow up, and the flow rate was 1.2 lpm.The only way to look up temperature other than graph was on a flash drive once through with the therapy.Ms&s discussed the causes of heat generation and checked the temperature with an alternate source.Per follow up 2 on 27jan2021 via charge nurse, the therapy was discontinued and used blanketrol.The device with serial number ((b)(4)) was checked and cleared and kept in service, while the device ((b)(4)) was taken out of the service.

Event Description

It was reported that the baby's temperature was up to 34.3c and the target temperature was 33.5c on the arctic sun device.The nurse wanted to know whether they would look up the temperatures other than the graph.The water temperature was 10c, the trend had one arrow up, and the flow rate was 1.2 lpm.The only way to look up temperature other than graph was on a flash drive once through with the therapy.Ms&s discussed the causes of heat generation and checked the temperature with an alternate source.Per follow up 2 on 27jan2021 via charge nurse, the therapy was discontinued and used blanketrol.The device with serial number ((b)(6) ) was checked and cleared and kept in service, while the device ((b)(6) ) was taken out of the service.

Manufacturer Narrative

The reported issue was unconfirmed.No root cause could be found because the reported event was unconfirmed.Nurse wanted to know if they could look up temperatures other than the graph.Water temperature was 10c, trend had one arrow up, and flow rate was 1.2 l/m.Only way to look up temperature other than graph was on a flash drive once through with therapy.Ms&s discussed causes of heat generation and checking temperature with alternate source.Per follow up, discontinued therapy and used banketrol.Device dyeny016l was checked and cleared and kept in service.It is unknown if the device was influenced by the reported failure, however the device met specifications during evaluation.The device was in use on a patient.A dhr review was not required as the investigation was unconfirmed.Therefore, no additional action is required at this time.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as the investigation was unconfirmed.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.H3 other text : the device was not returned.

• 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
• MDR Report Key: 11326651
• MDR Text Key: 232527319
• Report Number: 1018233-2021-00492
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other