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

Model Number	ATLS24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
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.The bowl was run a couple of times using saline.During the runs there was no bowl lift, leaks or pump speed error messages noted.The reason for return was visually confirmed by the video provided by the customer, however it could not be duplicated in the lab.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 an autolog one source pack and autolog iq instrument, it was reported that patient blood was collected during the case and the customer attempted to process the blood however the autolog iq instrument failed to draw the blood from the reservoir.The wash lines were open and the reservoir clamp was open.The device and instrument were replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the issue could be where the red stripe was positioned in the fluid sensor, it was obscuring the optical sensor.The customer felt it was more likely a disposable issue rather than an instrument issue.There is variation with where the red stripe is positioned and often this tube needs to be maneuvering.Medtronic received additional information that they may have worked out what the issue was as this device has had similar issues since.It seemed that the tightening spring that caused the occlusion arm to clamp up against the tubing in the pump raceway was not strong enough to cause adequate pressure to maintain occlusion.Therefore, as the pump was turning, the pressure was not adequate to draw fluid from the reservoir into the wash bowl.

• Brand Name: AUTOLOG ONE SOURCE PACK
• 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: 22529046
• Report Number: 9617601-2025-00647
• Device Sequence Number: 20704956
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: (01)00643169108363(17)260310(10)0229060923
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/17/2025

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: 03/10/2026
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0229060923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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