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

Model Number 560BCS1

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of this bio-console instrument the mainframe smoked and the screen was black.The hospital had only one extra corporeal membrane oxygenation (ecmo) device, which was the host of bio-console 560.Using ecmo, the patient could not be rescued.The hand crank was required urgently.The customer stated that the hospital has only one ecmo machine, and there was no new machine to replace it in the remaining time after using the hand crank.The hand crank was used for nearly 3 hours.This instrument was used to rescue the patient.The customer stated there is no allegation that the issue with the bio-console contributed to the patient¿s death.The customer stated that as the ecmo patient could not be rescued it is currently impossible to determine whether the issue with the bio-console caused any adverse patient effects.Additional information: the length the patient was on ecmo is not available.The length of time the bio-console had been used by the patient when the issue occurred is not available.Information on whether the bio-console had been turned on and off more than once by the clinician during the clinical procedure is not available.The customer stated that the bio-console instrument had been used before to rescue many ecmo patients.There is no allegation against the 560a.The 560bcs1 was the host.The statement of ¿this instrument was used to rescue the patient¿ is in reference to the ecmo procedure.

Manufacturer Narrative

Medtronic investigation complaint was confirmed for the reported issues of the mainframe smoking (burnt board) and a black screen.The issue was resolved by replacing the assy 560 bioconsole syscon 2b02002 (part number: 90909004) with a new version of the part.Additional actions will be documented in a medtronic corrective and preventative action plan (capa).The customer stated there is no allegation that the issue with the bio-console contributed to the patient¿s death.Review of the complaint file indicates sufficient information was provided for completion of this investigation.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.

• 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
• MDR Report Key: 11745058
• MDR Text Key: 247940144
• Report Number: 2184009-2021-00025
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: 00763000236526
• Combination Product (y/n): N
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: 04/01/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 41 YR