MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	560A
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 at an unspecified time, this bio-console 560 had an error code 52 (sc mpu mc speed control gain soft error) and the external motor drive instrument had a broken cable and was locked so could not be used.The use of the instrument was unknown.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
B.5.Additional information.Medtronic received information that prior to use of a bio-console 560 instrument and external motor drive instrument , it was reported that the bio-console 560 had an error code 52 (sc mpu mc speed control gain soft error) and the external motor drive had a broken cable and was locked so could not be used.Use of instrument was unspecified.There was no patient involvement, so no adverse effect occurred.Device evaluation:the reported broken cable problem was verified during service.Service technician found that motor running at maximum if cable is touched.Note:instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center.Device evaluation not yet complete.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
Device evaluation summary: during field service the reported issue of the external motor drive having a broken cable was verified during service.The service technician found that the motor was running at maximum if the cable was touched.The instrument was sent to the service depot for further service.The broken cable was not verified during depot service.During the depot service it was noticed that the work positioner assembly was missing.The issue was resolved by replacing the work positioner assembly and magnet cover.Preventive maintenance was performed per specifications.Additional information b5: medtronic received additional information that there was no damage to the bio-console 560 instrument and no repair is needed.No further action required.Correction b5: use of the instruments was unspecified.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: MOTOR EXTERNAL DRIVE
• 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: 21571648
• Report Number: 2184009-2025-00409
• Device Sequence Number: 8737509
• Product Code: DWA
• UDI-Device Identifier: 00613994647832
• UDI-Public: 00613994647832
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191077
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 560A
• Device Catalogue Number: 560A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 04/15/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/04/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2016
• 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