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

Model Number	ATLS24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
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
Medtronic received information that prior to use of an autolog one source pack, it was reported that air was seen in the line, and customer also noticed a leak by the bowl.Customer was able to read the disposable exchange material and resolved the problem.The device was replaced.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Correction b5: medtronic received information that prior to use of 2 autolog one source packs, it was reported that for pli 10: customer noticed a leakage through the bowl and in pli 20: customer observed that the device filled, but found air on the line, during check, customer observed leakage by the bowl.The devices were replaced.There was no patient involvement, so no adverse effect occurred.Additional info b5: medtronic received additional information that there was no damage noted in the instrument or the disposable.The only abnormality, identified by the customer, was the identification of liquid coming out from under the equipment.The leak occurred during assembly of the device.The customer stated that the issue was identified before the equipment was made available for the surgical procedure.There was no contact with fluids.There were no error warning messages.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
Medtronic received information that prior to use of the autolog one source packs, it was reported that the customer noticed a leakage through the bowl in one pack (pli 10) and as the second wash kit filled, air was found in the line, the wash kit was checked and a leak was found from the bowl (pli 20).The devices were replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was no damage noted in the instrument or the disposable.The only abnormality, identified by the customer, was the identification of liquid coming out from under the equipment.The leak occurred during assembly of the device.The customer stated that the issue was identified before the equipment was made available for the surgical procedure.There was no contact with fluids.There were no error warning messages.Medtronic received additional information that the problem was identified during the assembly of the disposable material, at this stage there was no contact with the patient's blood.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
Device evaluation summary: visual inspection shows no outward signs of damage or abnormalities.No fin, straw, or dimple plate damage was noted, no signs of holes or cracks were detected.The bowl was run a couple of times using di water.During the runs there was no bowl lift, leaks, air bubbles or pump speed error messages noted.Reason for the return was not confirmed.Additional information h6.2 eval code method (fdm/annex b): this field was updated.Additional information h6.3 eval code result (fdr/annex c): this field was updated.Correction d3 mfr name postal code correction d4 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: 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 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: 20118191
• Report Number: 9612164-2024-04007
• Device Sequence Number: 7277409
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: (01)00643169108363(17)251020(10)0228325565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 10/20/2025
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0228325565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/22/2024; 10/19/2024; 09/19/2025
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/29/2024; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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