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

Model Number	ATL2001
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Noise, Audible (3273)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information that during use of the autolog wash kits, it was reported that the customer noted the centrifuge bowls were damaged and blood had leaked to the instrument and the ground.The devices were replaced to complete the procedure.There was no additional adverse patient effect because of these issues.The customer also stated that the patient's anatomy was not the cause of this problem.Medtronic received additional information that the instrument had not been damaged yet, but it had been in use for more than five years and was operating at full capacity in the department.There was visual, audible, and performance abnormalities noted.During the use of the wash kits, the sound was louder than before.During the cycle, the problem occurred when the first centrifugal bowl was first cleaned.The cleaning kit was replaced after the problem was found.The issue occurred with an unknown fill level, and there was no error message, only the centrifuge bowl was found to be broken.Timely detection of the leak meant that no additional transfusion of allogeneic blood was required.Medtronic received additional information that at present, the instrument is running normally after replacing the consumable.

• 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: 21504614
• Report Number: 9617601-2025-00217
• Device Sequence Number: 19945564
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/03/2025

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: 03/03/2024
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 224279652
• 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: 03/07/2023
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• 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