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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/05/2025
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 at an unspecified time, this autolog iq instrument was not saving blood and was letting it all spill into the waste bag.The use of the instrument was unknown.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Additional information h6.4 eval code conclusion (fdc/annex d): 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.
Additional Manufacturer Narrative
Device evaluation summary: the reported blood into the waste bag issue was verified during service.The service technician observed that the optics were dirty, and cleaned dried blood and debris.Led 10 was initially unresponsive, and the led gain was at 107% and led current was 41ma.The customer also reported vacuum failure.The history error log recorded vacuum system 032 036.These issues were resolved by readjusting and calibrated the emitter and detector gain to 40ma% and 100% on the system controller pcba board.The service technician flushed the dried blood from the vacuum system, and replaced the fluid trap.Preventive maintenance was performed as per specification.Note: 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.Additional information b5.Medtronic received additional information that it is unknown the amount of blood loss and whether a transfusion was required due to the reported issue.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: 23508625
• Report Number: 2184009-2025-01436
• Device Sequence Number: 18404104
• Product Code: CAC
• UDI-Device Identifier: 00643169982864
• UDI-Public: (01)00643169982864(11)210816
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/28/2025

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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 11/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/26/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2021
• 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