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

Model Number 50000000E

Device Problems Insufficient Heating (1287); Overfill (2404)

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

Event Date 12/07/2020

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 user had filled artic sun device with 1500cc water and still at 1 bar.Nurse concerned water temperature not getting warm enough.Nurse did not empty arctic gel pads the first time they filled.Only alerts that went off was the low reservoir alert 03 (water reservoir low) and alert 112 (confirm return to cooling phase) starting in cool mode.Patient completed hypothermia now in maintenance phase.Target temperature was 36.5c and patient temperature was 35.9c.Rectal probe was in place and checked placement.Flow rate was 2.1 l/m and had nurse empty pads, then check reservoir.Bars now at 4.Also had nurse put patient in normothermia mode.Water temperature now at 36c, flow rate was 2.2 l/m, patient temperature started going up by end of conversation, the temperature was 36c.Nurse would call back if any other issues.

Event Description

It was reported that the user filled the arctic sun device with 1500 cc water and still at 1 bar.The nurse was concerned about the water temperature was not getting warm enough and did not empty the arctic gel pads the first time they filled.The alerts that went off was the low reservoir alert 03 (water reservoir low) and alert 112 (confirm return to cooling phase) started in a cool mode.The patient completed hypothermia in the maintenance phase.The target temperature was 36.5 c and the patient temperature was 35.9 c.The rectal probe was in place and checked the placement.The flow rate was 2.1 lpm and the nurse emptied the pads and checked the reservoir.The bars were at 4.Also the nurse puts the patient in normothermia mode.The water temperature was at 36 c the flow rate was 2.2 lpm and the patient temperature was increasing by the end of the conversation the temperature was 36 c.The nurse would call back if any other issues.

Manufacturer Narrative

The reported event was confirmed.The root cause of the reported issue was the device was overfilled due to filling before emptying the pads by the nurse which resulted in the device unable to properly heat the water.The device did not meet the specifications and was influenced by the reported failure.The device was used on a patient.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: " the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Instruction for properly filling the reservoir: 1.Fill the reservoir with sterile or distilled water only.2.Four liters of water will be required to fill the reservoir at initial installation 3.Add one vial of arctic sun temperature management system cleaning solution to the sterile or distilled water.4.From the patient therapy selection screen, press either the normothermia or hypothermia button under the new patient heading.5.From the hypothermia or normothermia therapy screen, press the fill reservoir button.6.The fill reservoir screen will appear.Follow the directions on the screen." 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 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11092704
• MDR Text Key: 227032851
• Report Number: 1018233-2020-22131
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other