MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560 USER INTERFACE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number A09075001

Device Problem Smoking (1585)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of the bio-console instrument the customer observed smoke emitted from the user interface at start up.During inspection of the bio-console base, the customer found u38 on the system controller module to be burnt.The instrument was changed out with a backup and there was no resulting adverse patient effect.Additional information states that the issue occurred when the bio-console was turned on for the first time for this clinical case.The event did not occur during powering cycling.The unit was turned on and off more than once, but unsure how many times, but definitely more than2 or 3 times.Fluids were running through the pump when event occurred.

Manufacturer Narrative

Device evaluation summary: the reported smoke emitted from the user interface and burned u38 were verified during service.The issue was resolved by replacing the assy system controller module.After the assy system controller module was replaced the instrument was run for 72 hours with no problems noted.The instrument was retested and no problems noted.Preventive maintenance was performed per specifications.Conclusion: complaint confirmed for the reported smoke emitted from the user interface and burned u38 were verified during service.It was anticipated that although there was fluid pumping when this occured, the issue was a result of the powering on and off during this cycling.This occurrence is the result of the replacement of a component.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: BIO CONSOLE 560 USER INTERFACE
• 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: 17388935
• MDR Text Key: 319761452
• Report Number: 2184009-2023-00857
• Device Sequence Number: 1
• Product Code: DWA
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A09075001
• Device Catalogue Number: A09075001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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