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

Model Number 560BCS1

Device Problems Display or Visual Feedback Problem (1184); Obstruction of Flow (2423); Power Problem (3010)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 07/15/2023

Event Type  Injury  

Event Description

Medtronic received information that during use of a bio-console instrument, it was reported that the patient became unconscious due to falling from a height and was admitted to the hospital at 12:17 on (b)(6), 2023.The patient had acute respiratory distress syndrome (ards).Because oxygenation was difficult to maintain, extra corporeal membrane oxygenation (ecmo) was performed on (b)(6).At 06:20 on (b)(6), when the patient was using the ecmo machine, the screen suddenly went black, the magnetic levitation pump stopped, the patient's blood pressure dropped to 70/40mmhg, and the oxygen saturation dropped to 70.The customer immediately started the robot hand shaking mode, and reported to the equipment department and manufacturer for repair at the same time.The engineer checked the instrument and measured input power voltage was normal, and the host connection test was also normal.It was initially determined that the internal power conversion module of the host was damaged.The manufacturer rushed to the scene at 10:00 with a spare machine.After inspection, the screen was broken.At 10:20 after replacing the screen, the machine could be used normally after debugging the parameters.The patient's blood oxygen saturation slowly returned to normal values.Situation of combined medication/device: used with continuous renal replacement therapy (crrt) and ventilator.The instrument was used to complete the procedure.There was no additional adverse patient effect associated with this event.Medtronic received additional information that hand crank had just been used for a short time for about 10 minutes, which was caused by an unskilled operation.

Manufacturer Narrative

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.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.

Manufacturer Narrative

Device evaluation:the reported black screen/power issue was verified during preliminary service.The issue was resolved by replacing the sub-assy ui 560 bio-console.Preventative maintenance/post repair testing was performed per specifications.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.

Manufacturer Narrative

Correction additional code: img (annex g) was updated.Additional information b5.Medtronic received additional information that the medication and the continuous renal replacement therapy (crrt) and ventilator was not required because of the issue with the bio-console instrument.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: 17955336
• MDR Text Key: 325897111
• Report Number: 2184009-2023-00996
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: 00763000236526
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female