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 07/26/2022

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a bio-console instrument, the customer reported low battery and would not charge.The instrument was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the batteries were deep-cycled by the customer.Somehow the power switch at the back of the device in the off position.Batteries (lot: 0011019087) were installed on 31-mar-2022.The customer did not state how long the battery lasted, just that it was getting lower and they decided to change it out.Additionally, the customer was setting up for a case and was running the pump and they noted that they were on battery power and decided to change out the unit.Battery power was required because the switch on the back of the unit had been switched off.The customer was unsure how the unit was knocked to the off position.The customer stated that there was no patient involvement so the hand crank was not used.

Manufacturer Narrative

Device evaluation summary: the reported battery issue was verified during service.Technician observed, the battery level was at one red bar.Ac power failure alarm was active.Technician verified instrument was plugged in to ac power and noted that the power switch on the back of the unit was off, turned switch on to clear ac power failure alarm.Technician replaced both batteries as a precaution due to deep cycling.Preventive maintenance was completed per specifications.Instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center.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 h3.2 (dev ret to mfr?): this field was selected in a previous report (2184009-2022-00228) in error as the instrument was analyzed in the facility by a medtronic field service technician.The instrument did not return to a medtronic facility for analysis.Correction h8 (usage of device): this field has been updated to reuse.Conclusion: the complaint was confirmed for the reported battery issue.As the batteries had been deep cycled the expected amount of time these batteries may be used is unknown.The service technician stated that the instrument will power off if the batteries get too low, so they do not get damaged.So deeply discharged should not happen.The service technician stated that they think that they would have charged back up, however it could take a day or two to get them back to full charge so if our technician found low batteries (below 12.75 volts) they would have replaced them.This instrument was manufactured in 2010; batteries are to be replaced every four years per the preventive maintenance schedule.A review of complaint and service records for august 2018 through august 2022 (>4 years) associated with this instrument found no other instances of battery replacement.The batteries met their lifecycle requirements.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.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: 15281569
• MDR Text Key: 305503614
• Report Number: 2184009-2022-00228
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: 00613994450463
• 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: 06/01/2023

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: 07/26/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2010
• 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