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

Model Number 560

Device Problems Electrical /Electronic Property Problem (1198); Battery Problem (2885); Power Problem (3010)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported unspecified defect was verified during depot service.The service technician observed that the touch screen had misalignments and it was difficult to control the user interface (ui).The service technician found errors 9, and 68 in log file.The service technician also observed that the dc-output of the power supply was unstable (between 26 - 27v), and the green led on the base unit kept flashing very fast.The back-up batteries were overdue since december 2022.The issue was resolved by replacing the back up batteries and power supply and clearing the error log.The service technician also performed service updates according to the procedure, ui touch screen gasket update, rpm pot bushing (recoil) update and base software version 2.B02.003 and fpga, system controller replacement.Preventive maintenance was completed was performed per specifications.H4 (device mfg date): the manufacturing date is month and year valid.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.

Event Description

During testing/ maintenance by the facility's bio-med technician this bio-console instrument had an unspecified defect found during the service.This was detected during service so there was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

Additional information b5: medtronic received additional information that the batteries were installed at a preventative maintenance on the 12th of december 2018.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.B.5: during preventive maintenance, this bio-console instrument had an unspecified defect.Correction d.5:oper of dev: this has been updated to other and service technician correction.E.1:initial reporter has been updated to medtronic service technician correction.E.2 and e.3:hcp <(>&<)> occupation updated to no and non-healthcare professional additional information: conclusion: batteries are expected to perform for up to 3 years from the date of battery manufacture.A review of complaint and service records associated with this unit found no other instances of battery replacement within 3 years.The batteries met their life cycle requirements.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
• 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: 16990346
• MDR Text Key: 315829524
• Report Number: 2184009-2023-00317
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2023

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: Other
• Device Model Number: 560
• Device Catalogue Number: 560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 07/24/2023
• Supplement Dates FDA Received: 06/21/2023; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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