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

Model Number 560BCS1

Device Problem Battery Problem (2885)

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

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of a bio-console base instrument, it was reported that as soon as the instrument was unplugged within 30 seconds a critical battery message was observed.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the displayed battery charge indicator and battery alarms were working appropriately.A hand crank was not used to maintain flow.To solve the issue the instrument was plugged in and then switched out, the switch time was 10 seconds.Medtronic received additional information that battery power was required because the patient needed to be transported from the operating room (or) to the coronary care intensive care unit (7icu).

Manufacturer Narrative

Device evaluation summary: the reported low battery after 30 seconds was verified during service.The service technician observed that both batteries measured above 13vdc although not able to maintain power output.The issue was resolved by replacing the batteries.The service technician verified that the instrument operated on battery power for 5 minutes without a significant drop in battery power and without any low battery warnings.The service technician stated that it was not certain that the battery had a defect versus a failure to do with improper charging causing the battery to degrade prematurely.The service technician verified the proper operation of the power supply, verified the proper operation of the uninterrupted power supply, switching via the service mode, verified the proper operation of the on screen display displaying the correct warning and icons as power was switched from ac to battery and verified the proper operation of the led indicator on the base when switching between ac power and battery power.The battery had been installed in the instrument on 23 march 2023 and the battery removed from the instrument was lot number 13251969.Preventive maintenance was performed per specifications.Note: the instrument was analyzed in the facility by a medtronic field service technician.The instrument did not return to a medtronic facility for analysis.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

Conclusion: complaint confirmed for the bio-console instrument's depleted batteries.The issue was verified during service, and resolved by replacing the batteries.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.Note: 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 other instances of battery replacement within 3 years.The batteries did not meet 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 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: 17029286
• MDR Text Key: 316198308
• Report Number: 2184009-2023-00359
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00643169315822
• UDI-Public: 00643169315822
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 81 KG