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

Model Number	ATLGIQ
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported leak issue was not verified during service.Service technician found unit to have had a blood/fluid spill within the centrifuge.Service technician cleaned centrifuge and level sensors, and operated the unit with wash kit and water.Was unable to experience holding bag fluid draining into reservoir.Unable to duplicate reported issue.Service technician identified the level sensor was operating erratically with fluctuating voltages.Replaced optic cables.Tested the level sensor voltages, and it was steady and achievable.Preventive maintenance was performed as per specification.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 iq instrument, it was reported that the holding bag fluid leaked into the reservoir.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Medtronic received additional information that there was no damage noted on the instrument or the disposable.No error warning message appeared.Customer did not track the amount blood loss as a result of this leak.And no transfusion was 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.
Additional Manufacturer Narrative
Medtronic received additional information that the packed/cleaned rbc¿s from the holding bag was draining into reservoir.This would have been through the tubing manifold, mounted in the clamp housing, and into the cardiotomy reservoir.Not back through bowl/centrifuge areas.The reservoir is under negative pressure, thus if the iq tubing were not occluding fully in clamp housing, it would have a pathway from holding bag to cardiotomy reservoir.H6.3 eval code result (fdr/annex c): this field was updated.Additional information h6.4 eval code conclusion (fdc/annex d): this field was updated.Additional information d.4 unique identifier (udi) # this field was 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 IQ
• 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: 22019136
• Report Number: 2184009-2025-00652
• Device Sequence Number: 9446964
• Product Code: CAC
• UDI-Device Identifier: 00643169982864
• UDI-Public: (01)00643169982864(11)220426(21)10992
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K181954
• 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,Followup
• Report Date (Section B): 07/31/2025

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: ATLGIQ
• Device Catalogue Number: ATLGIQ
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/08/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/05/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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