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

Catalog Number 50000000E

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

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

Event Date 02/22/2024

Event Type  malfunction  

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.

Event Description

It was reported that they treating a patient at 36c.The patient has been 34.8c.Rewarm was started around midnight, but the patient was still at 34.8c.When started rewarm, they adjusted the cool target to 35c to rewarm from 35c at 0.1c/hr.Flow 2.2lpm.Water 30.9c.Esophageal probe in use.Rewarm settings were set to rewarm from 35c to 37c at 0.1c/hr.Patient up to 34.9c at this time.Confirmed they adjusted the rewarm from target recently.Nurse then stated that earlier they received alert 113 (reduced water temperature control).Water level 5.Heater command was 100 percentage.System hours were 979.5.Pump hours were 832.9.Walked nurse through draining excess water from the circulation tank.They stated they did not fill the reservoir but unsure if anyone else did.Water temperature up to 34c by the end of draining.Explained how overfill can occur.Therapy continued.

Manufacturer Narrative

Upon further review of investigation, bd has determined that this mdr is not reportable as investigation confirmed it is a use related.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 they treating a patient at 36c.The patient has been 34.8c.Rewarm was started around midnight, but the patient was still at 34.8c.When started rewarm, they adjusted the cool target to 35c to rewarm from 35c at 0.1c/hr.Flow 2.2lpm.Water 30.9c.Esophageal probe in use.Rewarm settings were set to rewarm from 35c to 37c at 0.1c/hr.Patient up to 34.9c at this time.Confirmed they adjusted the rewarm from target recently.Nurse then stated that earlier they received alert 113 (reduced water temperature control).Water level 5.Heater command was 100 percentage.System hours were 979.5.Pump hours were 832.9.Walked nurse through draining excess water from the circulation tank.They stated they did not fill the reservoir but unsure if anyone else did.Water temperature up to 34c by the end of draining.Explained how overfill can occur.Therapy continued.

• 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: 18874487
• MDR Text Key: 337317704
• Report Number: 1018233-2024-01229
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Date Manufacturer Received: 04/26/2024
• 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