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); Increase in Pressure (1491)

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

Event Date 09/08/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use of this bio-console instrument when the equipment was connected to a patient on extra corporeal membrane oxygenation (ecmo), when doing the pressure calibration on p1 and p2 the screen flashed and there was a mark for very high pressure.Emergency was pressed and manual had to be passed.The screen would then no longer turn on.The instrument was replaced with a backup and there were no adverse patient effects associated with this event.The customer was contacted regarding whether the hand crank was used and they stated that the initial information provided is all the information they have on this incident.The initial information provided did not state that the hand crank was required.

Manufacturer Narrative

Device evaluation summary: the reported pressure issue was verified during service.The service technician noted that the warranty seal was broken.The service technician noted that when the instrument was turned on, it displayed error 71.The error log had errors 59, 60, 61, 62, 70, and 71, these are calibration errors.The service technician recalibrated the instrument, however the system controller would not retain the calibration coefficients.The service technician found corrosion on the system controller module.Customer had replaced the batteries with non-approved batteries and this had damaged the battery cable.The service technician also noted that one of the blind connectors was broken and one of the fans has been disconnected from the system controller.During preventive maintenance, the service technician found two pressure leaks.The issues were resolved by replacing the system controller, batteries, battery cable, blind connector and mp module.The service technician was unable to duplicate or verify the display issue.Preventive maintenance was performed per specifications.Conclusion: complaint confirmed for the reported pressure issue.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.Note: this instrument has an indication for use of up to 6 hours; refer to medtronic instructions for use.Note: this unit was manufactured in 2012; batteries are to be replaced every 4 years per the preventive maintenance schedule.Batteries met their lifecycle requirements.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: 17117712
• MDR Text Key: 317328153
• Report Number: 2184009-2023-00507
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: 00613994450463
• Combination Product (y/n): N
• Reporter Country Code: PA
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2023

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: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2012
• 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