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

Catalog Number 50000000E

Device Problem Lack of Effect (4065)

Patient Problem Chills (2191)

Event Date 03/30/2024

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.

Event Description

It was reported that the intensive care unit nurse stated they had been trying to cool the patient on arctic sun device for three hours and they had not yet reached target.They were looking for suggestions as to why patient temperature (pt) was 34.7c, targeted temperature (tt) was 33c, water temperature (wt) was 5.3c.Discussed potential reasons and discovered the patient was experiencing micro shivers they were currently trying to address.Additionally, the patient was 96kg with medium pads in place.Explained this was not likely enough pad coverage and confirmed there was exposed abdomen.They would place a universal pad and continue to address the heat generation.Explained they could call back if these interventions did not help the patient reach target.Advised they should perform diligent skin checks.No medical intervention was reported.

Event Description

It was reported that the intensive care unit nurse stated they had been trying to cool the patient on arctic sun device for three hours and they had not yet reached target.They were looking for suggestions as to why patient temperature (pt) was 34.7c, targeted temperature (tt) was 33c, water temperature (wt) was 5.3c.Discussed potential reasons and discovered the patient was experiencing micro shivers they were currently trying to address.Additionally, the patient was 96kg with medium pads in place.Explained this was not likely enough pad coverage and confirmed there was exposed abdomen.They would place a universal pad and continue to address the heat generation.Explained they could call back if these interventions did not help the patient reach target.Advised they should perform diligent skin checks.No medical intervention was reported.Per follow up information received via phone on 16apr2024, it was reported the patient was a male between 30-40 years old.Therapy was completed without any impacts.It was determined that the wrong size pad was being used.They added an universal pad to the abdomen area and this resolved the issue.

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.

• 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: 19106429
• MDR Text Key: 340907047
• Report Number: 1018233-2024-02078
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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: 03/30/2024
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 96 KG