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

Catalog Number 50000000E

Device Problems Overfill (2404); Device Sensing Problem (2917)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had been giving them an alert all day about patient inappropriately being cooled and inaccurate temperature control.Directed nurse to the event log.Device received alert 113 (reduced water temperature control).Patient temperature (pt) was 36.9c, targeted temperature (tt) was 37c, water temperature (wt) was 35.4c, chiller temperature (t4) was 7.1c, water reservoir level (wrl) was 5, mixing pump command (mpc) was 0 percentage, heater command was 100 percentage, flow rate was 1.7lpm, pump hours were 6694.2, system hours were 6960.4.Walked nurse through draining excess water from the circulation tank.Discussed how overfill could occur.Water temperature increased during call.Explained device would need to go to biomed if device continues to give alert 113.If alert did not return it was okay to continue to deliver therapy.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review of investigation, bd has determined that this mdr is not reportable.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.

Event Description

It was reported that the arctic sun device had been giving them an alert all day about patient inappropriately being cooled and inaccurate temperature control.Directed nurse to the event log.Device received alert 113 (reduced water temperature control).Patient temperature (pt) was 36.9c, targeted temperature (tt) was 37c, water temperature (wt) was 35.4c, chiller temperature (t4) was 7.1c, water reservoir level (wrl) was 5, mixing pump command (mpc) was 0 percentage, heater command was 100 percentage, flow rate was 1.7lpm, pump hours were 6694.2, system hours were 6960.4.Walked nurse through draining excess water from the circulation tank.Discussed how overfill could occur.Water temperature increased during call.Explained device would need to go to biomed if device continues to give alert 113.If alert did not return it was okay to continue to deliver therapy.

• 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: 18535542
• MDR Text Key: 333548303
• Report Number: 1018233-2024-00159
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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 Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• 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