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

Model Number 560BCS1

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Power Problem (3010)

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

Event Date 03/29/2021

Event Type  malfunction  

Event Description

During preventive maintenance on this bio-console instrument the user interface was unresponsive.This was detected during service so there were no adverse patient effects.Additional context: while replacing the system controller (mod0204 90909004 system controller replacement) on this bio-console instrument, the service technician observed that the system controller boards failed.The technician noted that the first new board failed on initial power up, the fans came on for a moment and the instrument shut down.The front panel showed that it was in diagnostic mode, but the user interface (ui) was unresponsive and dark.There was no connection between the system controller board and the laptop using the hyper-terminal.The second replacement board would power up.The instrument went into diagnostic mode, the technician performed the calibration procedure and testing in hyper-terminal with no problems.All errors would clear.The technician powered up the instrument in normal mode and the ui would show the medtronic splash screen, but would not go any further.The instrument alarmed after several seconds and diagnostic mode showed error codes 9, 21 and 37.The third replacement board presented with the same issues that the second board had with a mix of error codes 9, 21 and 37.The third replacement board came from a different lot number.The service technician tried one more board with the same results.They also tried to run the diagnostic with the plug-in boards removed and installed one at a time, but that did not give them any more information.The instrument was still giving error codes 9, 21 and 37 during diagnostic testing.A determination was made to send the instrument to the service depot for analysis and repair.

Manufacturer Narrative

Device evaluation summary: during preventive maintenance by service technician, the technician observed that the system controller boards failed.The issue was resolved by replacing the base unit cable assy ui and assy system controller module.Preventive maintenance was completed per specifications.Conclusion: complaint confirmed for an unresponsive user interface (ui).This occurrence was identified during preventive maintenance, therefore, there was no patient involvement.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.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
• 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: 17254183
• MDR Text Key: 318876838
• Report Number: 2184009-2023-00780
• 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: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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