MAUDE Adverse Event Report: PERFUSION SYSTEMS CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	560BC1
Medical Device Problem Codes	Increase in Pressure (1491); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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 prior to use of a bio-console 560 controller instrument, it was reported that the battery was not holding charge and dies when unplugged.And the pressure sensor seems to read too high according to the user.Use of instrument was unspecified.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that the battery was installed on (b)(6) 2022 and the lot number of the battery removed from the instrument was 0011198399.Device evaluation summary: the reported issue that the battery was not holding charge, and the instrument died when unplugged was verified during service.During inspection, the service technician found that the instrument was presenting a p2 error on-screen after the power on self-test (post).The service technician replaced the mp module to correct the problem.The service technician inspected the batteries and found the batteries to be measuring above 13vdc, the instrument was then run on battery for 15 minutes without a drop in battery power.The service technician replaced the batteries as a precaution.Preventative maintenance was performed per specifications.Note: the instrument was serviced in the facility by a field service technician.The instrument did not return to a medtronic facility for service/analysis.Correction g4.4 (pma / 510(k) #): this field has been updated.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: CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD
• 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: 20621353
• Report Number: 2184009-2024-00686
• Device Sequence Number: 18005387
• Product Code: DWA
• UDI-Device Identifier: 00613994450326
• UDI-Public: 00613994450326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 560BC1
• Device Catalogue Number: 560BC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2012
• 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