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

Model Number	560BCS1
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported display flickering was verified during service.During preliminary analysis service technician could boot up the instrument normally, the base unit displayed a flash after power on for few minutes, then service technician powered off the unit and powered again, the display of base unit was black, the user interface display was ok.The issue was resolved by replacing the cable assy, battery and calibrated.Preventative maintenance was performed 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.
Event or Problem Description
Medtronic received information that during use of a bio-console instrument, it was reported that the base unit display was flickering during operation.The use of the instrument was unknown.There was no adverse patient effect associated with this event.Medtronic received additional information that the batteries were defective, with one showing 12.7 v and the other 12.1 v.The batteries had been installed for over 4 years, and it was not possible to obtain the lot number as the information was unreadable.During motor use, the batteries lasted 10 minutes after the instrument was turned off.The customer was unable to specify why battery power was required.The battery alarms and the battery charge indicator were operating normally.

• 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: 22932053
• Report Number: 2184009-2025-01048
• Device Sequence Number: 13335819
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: (01)00763000236526(11)200406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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