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

Model Number	ATL2001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that during use of a custom tubing pack, suction and anticoagulant assembly, an autolog washkit and an autolog instrument an error message appeared stating, 'the centrifuge is operating too slowly.Please check the installation of the bowl,' and washing could not be performed. a strange noise (metallic sound) was heard from the bowl area.A saline leak from the bowl was also observed. the customer turned the power off and attempted to setup several times however, this did not resolve the issue.The device was replaced. it is unclear whether the problem was due to a defect in the disposable or in the main device. no patient complications have been reported as a result of this event.Medtronic received additional information that no damage was observed visually in the instrument or the disposable.The main unit was powered off and re-attached, however, the issue was not resolved.It was repeated several times.There was approximately 100¿150ml of fluid in the reservoir, approximately 300ml remaining in the 1000ml saline bag, and the waste bag was empty.Those were approximate values.The error/warning message was addressed by turning the power on and off, and the disposable was reset.There was no patient blood loss as a result of this leak.No unplanned blood transfusion was required.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the lid has bonded/melted to the bowl and no longer spins.This issue along with fin damage is a representative failure mechanism of bowl lift/leaking.The bowl could not be tested with the lid bonded/melted to the bowl.Reason for the return was confirmed with evidence of fin damage and the lid bonded to the bowl.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: 23358416
• Report Number: 9617601-2025-02150
• Device Sequence Number: 15671295
• Product Code: CAC
• UDI-Device Identifier: 00673978521862
• UDI-Public: (01)00673978521862(17)261221(10)230749709
• 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,Followup
• Report Date (Section B): 11/13/2025

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 Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 230749709
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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: Male