MAUDE Adverse Event Report: Perfusion Systems Performer CPB Support System; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY B

Model Number	R5100052
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that at an unspecified time, this performer console instrument had error codes and unstable flow measurement.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Device evaluation:the reported error codes and unstable flow measurements were verified during service.Service technician identified a possible failure in the flow measurement control board and the corresponding part was requested for functional testing.The flow measurement board was replaced.Functional tests were performed on the bio-pump speed and flow measurement.Positive results were obtained, with accurate flow measurements and the programmed speeds were operating correctly.During testing, alarm 046, related to fuse failures, was identified.The fuses were inspected and all were found to be in good condition.This indicated a possible irregularity in the power supply or the xp power supply board.The xp power supply board will be replaced and further functional testing will be 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.

• Brand Name: Performer CPB Support System
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY B
• 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 ; +353(091)708096
• MDR Report Key: 50270229
• Report Number: 3003793891-2026-00001
• Device Sequence Number: 10316130
• Product Code: DTQ
• UDI-Device Identifier: 00885074514857
• UDI-Public: (01)00885074514857(11)090317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: R5100052
• Device Catalogue Number: R5100052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2009
• 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