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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an autolog iq instrument, it was reported that blood leaked from the bowl into the centrifuge.It was not a lot of blood, but customer decided to change disposables.The initial disposable was discarded and is not available.Use of instrument was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: the reported blood leak issue was verified during service.Service technician observed while performing hlt noted that optics were difficult to calibrate.The issue was resolved by replacing cable assy level sensor.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.
Additional Manufacturer Narrative
Medtronic received additional information that the autolog iq instrument was not replaced to complete the procedure.The patient blood loss due to the leak was minimal, not measured by the customer.No blood transfusion was required due to the leak.Correction h6.3 eval code result (fdr/annex c) 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
Additional review of the event shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the malfunction reported could cause a a death or serious injury if it were to recur.The reported blood leak was from the disposable device rather than the instrument.The disposable device was reported separately via mdr #9617601-2025-01274.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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 blood leaked from the bowl into the centrifuge.It was not a lot of blood, but customer decided to change disposables.The initial disposable was discarded and is not available. use of instrument was unspecified. there was no adverse patient effect associated with this event.Medtronic received additional information that the autolog iq instrument was not replaced to complete the procedure.The patient blood loss due to the leak was minimal, not measured by the customer.No blood transfusion was required due to the leak.

• 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: 22794253
• Report Number: 2184009-2025-00946
• Device Sequence Number: 8511719
• Product Code: CAC
• UDI-Device Identifier: 00643169982864
• UDI-Public: (01)00643169982864(11)211101
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/09/2025

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: 08/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/24/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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