MAUDE Adverse Event Report: PERFUSION SYSTEMS AUTOLOG INSTRUMENT; APPARATUS, AUTOTRANSFUSION

Model Number	ATLG110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported issue of not transfusing the blood was not verified during service.Service technician was unable to duplicate the reported issue.Service technician ran the device as the customer would and found the device to be functioning as expected.Service technician completed a full diagnostic check and all tests passed.Post repair tests were completed per specifications.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 instrument, it was reported that it would not transfuse the blood.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the reported issue did not lead to additional loss of blood.The patient was already actively bleeding.The device would not process the blood.
Additional Manufacturer Narrative
Medtronic received additional information that the issue, where the blood would not process, was due to a clogging alarm.The problem occurred with both instruments, and the patient was bleeding due to a fatty liver.No leaks were observed in the used instrument or disposables.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 INSTRUMENT
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21398539
• Report Number: 2184009-2025-00269
• Device Sequence Number: 20801096
• Product Code: CAC
• UDI-Device Identifier: 00613994667670
• UDI-Public: 00613994667670
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 07/27/2016
• Device Model Number: ATLG110
• Device Catalogue Number: ATLG110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Unknown
• Patient Weight: 84 KG