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

Catalog Number	718-00
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fill tube not staying in place was against ifu and causes a hygiene risk.This work order has to be created to ensure full traceability, but the device would not be sent in for repair.Replacement of the fill tube would not solve the issue.Per follow up information received via email on 01feb2024, the issue was resolved with replacing the fluid delivery line, device will not be sent in.
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.H3 other text : the device was not returned.
Additional 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.
Event or Problem Description
It was reported that the fill tube not staying in place was against ifu and causes a hygiene risk.This work order has to be created to ensure full traceability, but the device would not be sent in for repair.Replacement of the fill tube would not solve the issue.Per follow up information received via email on 01feb2024, the issue was resolved with replacing the fluid delivery line, device will not be sent in.

• 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: 18739077
• Report Number: 1018233-2024-00821
• Device Sequence Number: 17950312
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: 00801741080197
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/10/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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