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	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note:device was tested by field service technician but final analysis results not yet available.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
During preventive maintenance by a service technician this bio-console instrument was not passing uninterruptible power supply (ups) test, charge current was fluctuating sporadically up and down in value.This was detected during service so there was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Medtronic received additional information that the batteries had been installed in the instrument on 11 may 2022.The batteries did not reach the end of their expected lifespan before they were replaced.The lot number of the batteries removed from the instrument was 0011198399.Device evaluation summary: during preventive maintenance by service technician, it was observed that the bio-console instrument was not passing the uninterruptible power supply (ups) test, the charge current was fluctuating sporadically up and down in value.The service technician also found that the batteries were passing the battery checks, but were not holding charge.The issue were resolved by replacing the power supply 28v and the battery,12v,6.5 ah,certified *2.Preventive maintenance was completed per specifications.Note: the instrument was serviced in the facility by a field service technician.The instrument was not returned to a medtronic facility for service/analysis.Update to h.6: fdd code added; fdr and fdc codes 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: 20661977
• Report Number: 2184009-2024-00693
• Device Sequence Number: 15511815
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: Other
• Device Model Number: 560BC1
• Device Catalogue Number: 560BC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2010
• 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