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

Model Number	ATLG110
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an autolog instrument, it was reported a bowl spill.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was no transfusion required.Biomed had no additional information about device, only that it had a blood leak.The technician assumed blood leaked through the bowl as this is only way a visible leak occurs.
Additional Manufacturer Narrative
Device evaluation summary: the reported bowl spill was verified during service.The service technician noticed blood leaking from the drain tube.During investigation, it was found that the centrifuge bowl height was not passing the level test and that the bowl height was incorrect due to a broken damper.The issue was resolved by adjusting the bowl height to proper specifications and by replacing the damper centrifuge assy.Preventive maintenance was performed per specifications.The instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return to a medtronic facility for service/analysis.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 b5: medtronic received information that during use of an autolog instrument, it was reported that a bowl spilt.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was no transfusion required.The bio-med technician stated that they had no additional information about the instrument, only that it had a blood leak.The technician assumed blood leaked through the bowl as this is the only way a visible leak occurs.Correction h6: patient codes (ime/annex e) and eval code result (fdr/annex c) updated.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: 21395831
• Report Number: 2184009-2025-00265
• Device Sequence Number: 15752742
• Product Code: CAC
• UDI-Device Identifier: 00643169201347
• UDI-Public: 00643169201347
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/03/2025

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 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: 03/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• 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 Sex: Unknown