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); Pumping Problem (3016)

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

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during normal use of this bio-console instrument screen blackout (monitor restart) occurred at around 11 o'clock on (b)(6) 2021.The customer stated that there had been no circuit replacement from (b)(6) 2021 to (b)(6) 2021.At that time, the centrifugal pump of the console was working.About a minute later, the monitor went down again, and this time, the centrifugal pump of the console stopped, so the pump was replaced with the hand crank urgently.After the console was restarted, it was confirmed that there was no problem, and the hand crank was replaced with an external motor again.After that, the instrument was replaced with an ecmo (extracorporeal membrane oxygenation) from another company.Additional information received confirms that the alarm sounded before the blackout.The alarm sound was different from that related to the battery, and customer noticed it immediately.The customer stated that there were no major patient problems at present and further information could not be provided.The patient is still on ecmo.There is no allegation against the external drive motor from the customer the hand crank was used.Due to how busy the hcp was the exact length of time of use is unknown.However, it was considered around one or two minutes as it was used from rebooting the instrument to checking the centrifugal pump operation.There was no information about the error codes.No one saw it at the hospital.Regarding the alarm sound, according to hospital staff, it was not familiar to them.The perfusion records are not available due to the restriction by the privacy regulation.

Manufacturer Narrative

Device evaluation summary: the reported display and pump issue was verified during service.Technician observed the event log confirms the reported issue described in the complaint.Error 68 was noted in the log at the time of failure, this failure indicates loss of communication from the base to the user interface.Suspect the user interface rebooted causing it to go blank during the reboot process.Unable to determine cause of motor stoppage during the second instance of error 68 approximately 2 minutes after the first instance.Based on the reported time frame of device power on (25 days), suspect this was caused by a software memory issue.There was no component failure, so no parts were replaced during this repair.Investigation conclusion: complaint confirmed for the reported display and pump issue.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: the indications for use (part number m937416a001) for this device indicate that the bio-console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12750295
• MDR Text Key: 280053664
• Report Number: 2184009-2021-00104
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• 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: 10/05/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention