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

Model Number 50000000

Device Problem Nonstandard Device (1420)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that hypothermia was initiated 2.5 hours ago on the arctic sun device.Nurse reported that they have had flow issues since initiation of therapy.Device kept alarming.Nurse stated that patient temperature was 35.8c, target temperature was 36c, water temperature was 23.8c and flow rate was 0.Nurse attempted to check event log and they could not get any of the buttons to work.Mss asked the nurse to cycle the power and a red screen appeared.Nurse was unable to clear the alarm.Mss recommended the nurse to change different device and send this one to their biomedical engineering department for repair.Per follow up information received on 06-apr-2022, the device was being used on a patient during reported event, with no patient injuries.It was unknown if the patient completed therapy on this device, but was sent to biomed.The biomed will be sending the device in for 2k hour preventive maintenance.Per sample evaluation result received on 22-apr-2022, the arctic sun device would not fill and then short filled due to intermittent connector on the manifold harness.Device would not cool due to failed mixing pump.Per sample evaluation result received on 18-aug-2022, it was noted that the double bend tube was found to be expanded.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable.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 actual/suspected device was inspected.

Event Description

It was reported that hypothermia was initiated 2.5 hours ago on the arctic sun device.Nurse reported that they have had flow issues since initiation of therapy.Device kept alarming.Nurse stated that patient temperature was 35.8c, target temperature was 36c, water temperature was 23.8c and flow rate was 0.Nurse attempted to check event log and they could not get any of the buttons to work.Mss asked the nurse to cycle the power and a red screen appeared.Nurse was unable to clear the alarm.Mss recommended the nurse to change different device and send this one to their biomedical engineering department for repair.Per follow up information received on 06-apr-2022, the device was being used on a patient during reported event, with no patient injuries.It was unknown if the patient completed therapy on this device, but was sent to biomed.The biomed will be sending the device in for 2k hour preventive maintenance.Per sample evaluation result received on 22-apr-2022, the arctic sun device would not fill and then short filled due to intermittent connector on the manifold harness.Device would not cool due to failed mixing pump.Per sample evaluation result received on 18-aug-2022, it was noted that the double bend tube was found to be expanded.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15321672
• MDR Text Key: 301008165
• Report Number: 1018233-2022-06792
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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