MAUDE Adverse Event Report: PERFUSION SYSTEMS CONSOLE R560BCS1 REFURB CONTROLLER; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number R560BCS1

Device Problems Display or Visual Feedback Problem (1184); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the reported issue of no display on the user interface (ui) and base was verified during service.The service te chnician stated that the customer had no display/no power on the instrument and installed new batteries and power supply, but this did not resolve the issue.The service technician diagnosed the issue as a failed system control board.The service technician installed a new assy system controller module and successfully powered on the instrument.The service technician then calibrated the new assy system controller board.Preventive maintenance was performed per specifications.Note: the instrument was evaluated by a field service technician within the facility.The instrument did not return to medtronic for service.Conclusion: the reported complaint of no display on the ui and base was verified during service.There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Trends for issues with this product are reviewed at quarterly quality meetings.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use of a bio-console instrument, it was reported that there was no display on the user interface (ui) and base.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.

• Brand Name: CONSOLE R560BCS1 REFURB CONTROLLER
• Type of Device: 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: 16851730
• MDR Text Key: 314771132
• Report Number: 2184009-2023-00222
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450319
• UDI-Public: 00613994450319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: R560BCS1
• Device Catalogue Number: R560BCS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1