MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number	ATL2001
Medical Device Problem Codes	Device Alarm System (1012); Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an autolog wash kit and autolog instrument, it was reported that the blood leaked from the bowl or blood entered the high-speed rotating part and an error appeared, and the instrument had a speed error.The wash kit and instrument were replaced to complete the procedure.There was no adverse patient effect reported with this event.Medtronic received additional information that the wash kit might have been damaged and leaked.The leak occurred in the centrifugal bowl.The specific timing of the leak during the cycle is unknown.There were audible abnormalities like noise during the rotation.A speed error was displayed and the wash kit and the instrument were replaced.The instrument worked for a while after the replacement but the same error message appeared again.The fill (fluid) level of the reservoir, holding, saline and waste bag at the time of the issue are unknown.It is unknown if there was patient blood loss.Medtronic received additional information that an unplanned transfusion was not performed because of the blood discarded from the bowl.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed fin damage.Additional visual inspection showed no straw or dimple plate damage.There were no signs of holes or cracks observed.Visual analysis of the returned device with fin damage is a representative failure mechanism of bowl lift/leaking.The bowl was run a couple of times using deionized water.During the runs there was no bowl lift, leaks or pump speed error messages noted.The reason for return was visually confirmed with evidence of fin damage noted but could not be duplicated in the lab.Section e initial reporter: the initial reporter's first and last names and phone number are unavailable due to regional privacy laws.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AUTOLOG WASH KIT
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21158395
• Report Number: 9617601-2025-00072
• Device Sequence Number: 15352204
• Product Code: CAC
• UDI-Device Identifier: 00673978521862
• UDI-Public: 00673978521862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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 Expiration Date: 06/16/2024
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 224859307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown