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

Model Number	560BCS1
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation:the reported error code 6(sc mpu external a/d converter -gain0 reference hard error), 7(sc mpu external a/d converter -gain1 reference hard error) and 100 was verified during service.During preliminary analysis the instrument displayed display error code 6,7 and 100 after booting up 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 560 instrument, it was reported that it displayed error code 6(sc mpu external a/d converter -gain0 reference hard error), 7(sc mpu external a/d converter -gain1 reference hard error) and 100 after booting up.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Correction b5: medtronic received information that during use of a bio-console 560 instrument, it was reported that it displayed error code 6(sc mpu external a/d converter -gain0 reference hard error), 7(sc mpu external a/d converter -gain1 reference hard error) and 100(sc mpu ss watchdog timeout hard error) after booting up.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Additional information b5: medtronic received additional information that the hand crank was not required when replacing the instrument and the flow to the patient was not affected.Updated device evaluation summary: the reported error code 6(sc mpu external a/d converter -gain0 reference hard error), 7(sc mpu external a/d converter -gain1 reference hard error) and 100 was verified during service.During preliminary analysis the instrument displayed displayed error code 6,7 and 100 after booting up.Service technician found that the battery had been used for more than 4 years.The voltage of the battery was 12.9 and 12.9, it needs to be replaced.The issue was resolved by replacing the assy system controller module -006,filter, 60 mm 30 hpi.The battery needs to be replaced but there is no stock, so instrument will be returned to customer without replacing the battery and they may change it if part available.Post repair testing 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.

• 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: 23494447
• Report Number: 2184009-2025-01427
• Device Sequence Number: 21060555
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: (01)00763000236526(11)200929
• 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,Followup
• Report Date (Section B): 11/19/2025

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: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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