MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number	ATL2001
Medical Device Problem Codes	Material Deformation (2976); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows fin damage.Additional visual inspection shows 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/noisy.The bowl was run a couple of times using di water.During the runs there was no bowl lift, leaks, noise or pump speed error messages noted.Reason for return was visually confirmed with evidence of fin damage.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 the autolog wash kit produced a rattling noise, similar to an improperly fitted washer kit prior to use.The issue persisted even after reinstallation.After draining the reservoir and running the autolog again, smoke was observed.Subsequently, after operating the pump, white crystalline deposits were found on the pump.The device was replaced.There was no patient involved.Medtronic received additional information that there was no damage noted in the instrument or the disposable.An error warning message did not appear.Although an issue was identified prior to use, due to emergency situation, the customer was unable to replace the product immediately.After briefly running the pump, the issue persisted, and the product was subsequently replaced.Medtronic received additional information that initially, a white foreign substance was reported.However, it was expected that the product's shaft collapsed, causing the material to be shaved off.Therefore, the customer confirmed that this was not a case of a foreign substance.Medtronic received additional information that they could not inspect the product directly to confirm whether a crack/leak was observed on the bowl due to the collapsed shaft.Medtronic received additional information that the noise occurred in the centrifuge.There was no damage noted in the instrument or disposable.The disposable product moved and its outer shaft was abraded.There was no performance issue.An error warning message did not appear.
Additional Manufacturer Narrative
Additional info b5: medtronic received additional information that the instrument could not be repaired due to an issue with a consumable item.Consequently, no service report has been issued.No further action required 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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21558100
• Report Number: 9612164-2025-01236
• Device Sequence Number: 15735162
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/24/2025

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: 07/07/2025
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 227095012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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