MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE

Catalog Number	718-00
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was low water flow pressure in the arctic sun device.The equipment turned off.Please do a comprehensive inspection, including replacing pumps and filters.Per sample evaluation results on 15feb2024.It was reported that the arctic sun device filled very slowly.Both pumps were at the wear limit, preventive maintenance recommended.Fill tube was dirty and fill tube must be replaced.
Additional 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 or Problem Description
It was reported that there was low water flow pressure in the arctic sun device.The equipment turned off.Please do a comprehensive inspection, including replacing pumps and filters.Per sample evaluation results on 15feb2024.It was reported that the arctic sun device filled very slowly.Both pumps were at the wear limit, preventive maintenance recommended.Fill tube was dirty and fill tube must be replaced.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue is inadequate maintenance.However, this cannot be confirmed.The device was evaluated upon receipt.Fill tube is dirty, fill tube must be replaced.Replaced fill tube.A dhr review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: "cleaning and maintenance routine cleaning and preventive maintenance should be performed on the arctic sun¿ temperature management system control module every 6 months at a minimum.This consists of cleaning the external surfaces, accessories and chiller condenser, inspecting the device, and replenishing the internal cleaning solution that suppresses microorganism growth in the water reservoir and hydraulic circuit.See the arctic sun¿ temperature management system service manual for additional information." correction: d,h 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 actual/suspected device was inspected.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE
• Common Device Name: FILL TUBE
• 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: 18855760
• Report Number: 1018233-2024-01186
• Device Sequence Number: 14279421
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: (01)00801741080197
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 718-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown