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

Model Number	560BC1
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a bio-console 560 instrument, it was reported that the batteries is not holding charge.During transportation the battery will not last very long, and had to be aborted.The unit was plugged back into ac power.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the battery was installed on august 2023.And the lot number of the battery removed from the instrument is 0011193821.The displayed battery charge indicator and battery alarms were working appropriately.
Additional Manufacturer Narrative
Device evaluation summary: the reported battery issue was verified during service.Service technician observed battery to last 8 minutes with both battery voltages measuring above 13vdc.The issue was resolved by replacing the batteries to correct problem of batteries not holding a charge.Preventive maintenance was performed as per specification.D9: instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center 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: 19740438
• Report Number: 2184009-2024-00409
• Device Sequence Number: 3615931
• 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: K131964
• 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
• Report Date (Section B): 07/15/2024

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: 06/24/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2011
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 68 KG