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

Model Number 560BCS1

Device Problem Complete Loss of Power (4015)

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

Event Date 09/27/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis and investigation : the reported powering off issue was verified during service.Service technician observed the mainboard is broken.The issue was resolved by replacing assy 560 bioconsole sys con and do the function test.Test result passed.Preventive maintenance was performed as per specification.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.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, it powered off automatically 30 minutes after booting.Use of instrument is unspecified and there is no adverse patient effects.Additional information was received that the hand crank was required to maintain flow during this procedure.

Manufacturer Narrative

The occurrence of the 560 bioconsole instrument powering off was confirmed by medtronic during service.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 instrument, 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: 10876045
• MDR Text Key: 217364929
• Report Number: 2184009-2020-00079
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000135447
• UDI-Public: 00763000135447
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• 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
• Patient Age: 75 YR