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

Model Number 95186-003

Device Problems Device Alarm System (1012); Battery Problem (2885)

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

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported battery issue was verified but not repaired.Technician powered 'on' the bio console and confirmed that the battery indicator displays 'battery low' and the 'alarm' is flashing, confirmed that there is no charging output from the motor pressure board and the batteries cannot be charged.The motor pressure board is defective, back-up batteries are completely depleted.This instrument is obsolete and the spare parts to repair it are not in stock and are out of production.Service advise to scrap this instrument.Instrument has been scrapped at service and repair.Conclusion: complaint confirmed for the reported battery issue but the instrument was not repaired.Medtronic did not perform service on the instrument as this model (550) is no longer being serviced.Medtronic service sent end of life letter to customer indicating service and support would be discontinued december 31, 2018.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at product quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.

Event Description

Medtronic received information that prior to use of a bio-console instrument, the customer reported battery is not charging, when plugged to power and there is still battery alarm.There was no patient involvement so no adverse effect occurred.

• 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: 17236838
• MDR Text Key: 318301824
• Report Number: 2184009-2023-00644
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K941921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

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: Health Professional
• Device Model Number: 95186-003
• Device Catalogue Number: 95186-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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