MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ONE SOURCE PACK ATLS00; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS00
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of an autolog one source pack, it was reported that due to recurring complaints of leaks in autolog disposables, x med identified the need to conduct video training, demonstrating the assembly of the disposable in the equipment.For this, a new disposable was used and assembly process began.The bowl fit into the centrifuge without major issues.After pressing the start button for the auto-test, as per the equipment manual, the centrifuge began to spin, emitting a loud friction noise.The test was stopped to check the disposable¿s positioning, which was correctly in place.Then the equipment was re-started to begin the processing cycle, simulating a surgical scenario.At this point, the display showed air in the tube.Several attempts was made to reposition it, until an experienced technician, who operates the equipment daily and was present for the recording, suggested a slight twist in the tube to adjust it.This worked, and the test proceeded without noise.However, at the end of the test, it was found that the disposable had signs of wear at the top of the bowl, apparently due to friction, but without rupture, as the test was stopped when the noise first appeared.It was decided to repeat the test with a new disposable, coincidentally from the same lot.Started the process, and as soon as the centrifuge began, the friction noise reappeared.As shown in the video, the noise decreased during centrifugation, seemingly as the part wore down, at which point the noise stopped.The centrifuge was then stopped, the disposable repositioned, but the display again indicated air in the tube, and it was unable to resolve the issue.The instrument used is up-to-date with preventive maintenance, the centrifuge was checked for balance, and it is an atlg model.See attached photos/video.Use of the devices was unspecified.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that damage was observed on the one source packs, wear was seen on the acrylic inside the bowl.Once it was sufficiently worn, the noise stopped.The noise came from the one source packs.There was no corresponding performance issue.The bowl or tube was reinstalled/replaced.There was no change in the noise but there was a change in noise when air was detected in the tube.The error message "air in the tube" appeared.The tube was reinstalled and a slight twist was made to adjust it.Since x med¿s initial intent was to create a training video, they opened the second disposable to verify whether they could reproduce the same issue and record it for medtronic.They achieved their objective.Medtronic received additional information that the fill level (fluid) of the reservoir, retention, saline and waste bag at the time of the problem was 200ml.
Additional Manufacturer Narrative
This is being submitted as a correction.Medtronic became aware of a second device due to an additional device returned within this complaint file.The reg report for the second device, was not submitted, and is being submitted today the device evaluation was captured in reg report: 9612164-2025-00737.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.
Additional Manufacturer Narrative
Correction h6.4 eval code conclusion (fdc/annex d) correction d.3 mfr name and postal code correction d.4 unique identifier (udi) #.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: ONE SOURCE PACK ATLS00
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21678665
• Report Number: 9612164-2025-01491
• Device Sequence Number: 15376986
• Product Code: CAC
• UDI-Device Identifier: 00643169108325
• UDI-Public: (01)00643169108325(17)250726(10)0227598367
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K830735
• 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): 08/07/2025

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: 07/26/2025
• Device Model Number: ATLS00
• Device Catalogue Number: ATLS00
• Device Lot Number: 0227598367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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