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

Model Number 560BCS1

Device Problem Electrical Overstress (2924)

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

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Initial device evaluation: the reported smoke coming from the bio-console instrument's base was verified during service.During the initial inspection of the base unit, a strong smell of burnt internal components was observed.After further investigation, excessive lint/dust on the fan filters was noted.After a complete inspection of all the boards and components, it was found that the system controller board had a blown fuse.Investigation is ongoing and additional information will be provided following completion.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of the bio-console instrument, external motor drives and centrifugal pump, the customer had an issue with a loud noise from the centrifugal pump.The customer re-seated the pump but the noise persisted.For peace of mind, the customer switched out the external drive motor (turned off power).After switching out the external drive motor, 30 seconds later there was a pop and then the bio-console instrument started smoking.The customer switched out the bio-console instrument and removed it.The customer stated that the first noise was just a 'little louder than usual' and the nurse picked up on the noise.When they customer changed to the new external drive motor, there was a louder 'screeching' noise, then a 'pop' then smoke billowing out of the sides of the bio-console instrument.The emergency hand crank was needed to maintain patient blood flow for approximately 5 minutes during the procedure.There were no adverse patient effects as a result of this issue.

Manufacturer Narrative

The bio-console base was analyzed during field service and the reported smoke coming from the bio-console base was verified.After a complete inspection of all the boards and components.Medtronic service found that the system controller board had an issue with a blown fuse.The issue was resolved by replacing the system controller board with a previous version of the board.Post-repair testing was performed per specification.This occurrence is the result of the replacement of a component used in the system controller board.At quarterly quality meetings.H7.8: updated to unknown additional codes: the imf has been updated to f23.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

The instrument had a strong smell of burnt internal components when serviced by medtronic; therefore the occurrence of ¿smoke¿ was confirmed.This was a result of an error with the 560 bioconsole system controller board; the board was replaced and post-repair testing was completed per specification.There was a potential for serious injury as the handcrank was used to maintain flow during use, however the user has confirmed no serious injury or patient harm resulted from this occurrence.Note, the 560 bioconsole is an inst rument, therefore a reusable device.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
• MDR Report Key: 11054948
• MDR Text Key: 227477744
• Report Number: 2184009-2020-00088
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: 00763000236526
• Combination Product (y/n): N
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1313-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention