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 01/17/2024

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a bio-console instrument, it was reported that the battery was not holding a charge.The customer moved the bio-console 560 instrument from picu to cl4.The customer stated that when they unplugged the bio-console 560 instrument immediately went to half yellow battery and by the time the customer got to the cl it was red.The customer plugged in the instrument and unplugged it again 15 minutes later and observed that the battery backup and the console were red.  the instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the batteries were installed on 7/15/2022, about 1 year and 6 months ago.The lot number of the battery removed from the instrument was 0011289907.A hand crank was not used.

Manufacturer Narrative

Device evaluation summary: the reported battery issue was verified during service.The unit was charged overnight at biomed.During the inspection the service technician found one of the batteries to be measuring below 12vdc.The issue was resolved by replacing the battery,12v, 6.5 ah,certified.The service technician verified proper operation of power supply by verifying output to be at 30.00vdc.The service technician also verified proper operation of base charging led and ui battery charge indicator.The service technician ran the unit on battery for 15 minutes without any problems.Preventive maintenance was performed per specifications.The instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return to a medtronic facility for service 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

Correction b5.Medtronic received information that during use of a bio-console instrument, it was reported that the battery was not holding a charge.The customer moved the bio-console 560 instrument from picu to cl4.The customer stated that when they unplugged the bio-console 560 instrument immediately went to half yellow battery and by the time the customer got to the cl it was red.The customer plugged in the instrument and unplugged it again 15 minutes later and observed that the battery backup and the console were red. the instrument was replaced.There was no adverse patient effect associated with this event.Correction additional codes: imf (annex f) health impact medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18674156
• MDR Text Key: 335248115
• Report Number: 2184009-2024-00070
• 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: 04/04/2024

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: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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