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	11/20/2023
Type of Reportable Event	Malfunction
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 the arctic sun device had been returned to depot due to broken and damaged screws and dirty tank.As per additional information received via email on 14nov2023, remove the broken bolt, change the level sensor, fill tube, put a screen protection and perform preventive maintenance 2000 hours.During preventive maintenance temperature was not reach to 30°, tank was full.Per sample evaluation results received on (b)(6) 2023, it was reported that the dirty fill tube.Per sample evaluation results received on (b)(6) 2023, it was reported that the black foam was damaged.
Event or Problem Description
It was reported that the arctic sun device had been returned to depot due to broken and damaged screws and dirty tank.As per additional information received via email on 14nov2023.  remove the broken bolt, change the level sensor, fill tube, put a screen protection and perform preventive maintenance 2000 hours.During preventive maintenance temperature was not reach to 30°, tank was full.Per sample evaluation results received on 20nov2023, it was reported that the dirty fill tube.Per sample evaluation results received on 24oct2023, it was reported that the black foam was damaged.
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.It was noted that the fill tube was dirty.Replaced fill tube.After the repair, the device underwent functional evaluation and passed all applicable testing.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." 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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d.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 the arctic sun device had been returned to depot due to broken and damaged screws and dirty tank.As per additional information received via email on 14nov2023, remove the broken bolt, change the level sensor, fill tube, put a screen protection and perform preventive maintenance 2000 hours.During preventive maintenance temperature was not reach to 30°, tank was full.Per sample evaluation results received on 20nov2023, it was reported that the dirty fill tube.Per sample evaluation results received on 24oct2023, it was reported that the black foam was damaged.
Event or Problem Description
It was reported that the arctic sun device had been returned to depot due to broken and damaged screws and dirty tank.As per additional information received via email on 14nov2023.Remove the broken bolt, change the level sensor, fill tube, put a screen protection and perform preventive maintenance 2000 hours.During preventive maintenance temperature was not reach to 30°, tank was full.Per sample evaluation results received on 20nov2023, it was reported that the dirty fill tube.Per sample evaluation results received on 24oct2023, it was reported that the black foam was damaged.
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.It was noted that the fill tube was dirty.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.Udi related data quality updates only: udi format updated with available product information per gudid as requested.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.

• 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: 18290982
• Report Number: 1018233-2023-08821
• Device Sequence Number: 6846632
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: (01)00801741080197
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 08/08/2024

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
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/29/2023; 01/05/2024; 08/08/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/08/2024; 08/12/2024
• 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