MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	560BCS1
Medical Device Problem Codes	Connection Problem (2900); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that at an unspecified time, this bio-console instrument had its bubble port working intermittently.Site tried multiple probes with no change.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Device evaluation:the reported bubble port working intermittently was verified during service.Service technician found the two batteries were old and were replaced.Service technician found the error number 59 sc mpu pm channel 1 gain, and 69 sc mpu ups open battery detected hard error.Nvram data did not persist.The issue was traced back to the system controller module and power supply which were both replaced.Service technician attempted general testing.The mp/p assembly failed to maintain pressure, and was replaced with assembly 560 bioconsole mp module.Service technician tested safety system board, all sensors performed as they should, tested bubble sensor with fully purged test loop, and tested along the line of the loop at different points.The only instance where the bubble sensor failed was on kinked tubing where the tubing was not being fully compressed by the bubble sensor leaving an air gap, which should result in a bubble detected error.The testing concluded after 4 hours.No additional problems were found.Preventative maintenance was completed per specifications.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: BIO CONSOLE 560
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 24017769
• Report Number: 2184009-2026-00033
• Device Sequence Number: 15753473
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: (01)00613994450463(11)101129
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K080824
• 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
• Report Date (Section B): 01/09/2026

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: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2010
• 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