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

Model Number 50000000

Device Problem Insufficient Cooling (1130)

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

Event Date 12/21/2021

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 patient was not getting to the target of 33c as quickly as expected on the arctic sun device.The nurse confirmed that the patient temperature was 36.3c, target temperature was 33c, water temperature was 5.8c and flow rate was 2.1lpm.Event log showed alert 0052 (extended period of cold water) which correlated with the therapy start time.According to nurse, the therapy started last night around 11.00pm.Nurse stated that the device had an alert 01/02 (patient line open /low flow).They have stopped the therapy, emptied the pads, disconnected, and reconnected with proper technique.The therapy was resumed, and no alerts were received.System diagnostics showed water level was 4, inlet pressure was -7.2psi, circulation pump command was 65percentage, mixing pump command was 100percentage, system hours were 2679 and pump hours were 2437.Trend indicator showed thermoneutral.Mss explained that the device appeared to be working appropriately now.Also discussed non-pharmacological interventions such as bair hugger to help with heat generation and advised nurse to look at hospital protocol regarding options for pharmacological interventions based on patient's bsas and temperature.

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 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 patient was not getting to the target of 33c as quickly as expected on the arctic sun device.The nurse confirmed that the patient temperature was 36.3c, target temperature was 33c, water temperature was 5.8c and flow rate was 2.1lpm.Event log showed alert 0052 (extended period of cold water) which correlated with the therapy start time.According to nurse, the therapy started last night around 11.00pm.Nurse stated that the device had an alert (b)(6) 2022(patient line open /low flow).They have stopped the therapy, emptied the pads, disconnected, and reconnected with proper technique.The therapy was resumed, and no alerts were received.System diagnostics showed water level was 4, inlet pressure was -7.2psi, circulation pump command was 65percentage, mixing pump command was 100percentage, system hours were 2679 and pump hours were 2437.Trend indicator showed thermoneutral.Mss explained that the device appeared to be working appropriately now.Also discussed non-pharmacological interventions such as bair hugger to help with heat generation and advised nurse to look at hospital protocol regarding options for pharmacological interventions based on patient's bsas and temperature.Per follow up information received on 04jan2022, it was stated that there was no injury on patient.The patient was able to complete therapy on device, and after patient finished therapy they had no other information on the unit.

• 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: 13168581
• MDR Text Key: 284714334
• Report Number: 1018233-2021-08690
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• 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