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 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported issue that the unit may not be charging was not verified during service.The service technician spoke with the perfusion team and they were not sure if the unit was left on, or if power was applied while unit was not plugged in.The service technician applied power to unit and it performed as required on battery power.Unit ran all systems while alarming that the power was not applied.Applied external power and alarm went away as required.In the process of further troubleshooting, it was noted that battery would charge, but slower than expected with amperage numbers at.501.Ran calibration checks of power system and all tests passed.The service technician replaced the battery ,12v,6.5 ah, certified as a precaution due to the lower voltage and slow charge.Retested unit, batteries charged at the expected rate and were at the appropriate charge.Ran functional tests and ran unit both on power and off power to ensure no issues.Preventive maintenance was performed per specifications.Note: the instrument was serviced in the facility by a field service technician.The instrument was not returned to a medtronic facility for service/analysis.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.

Event Description

Medtronic received information that prior to use of a biocon sole 560 instrument, it was reported that the unit may not be charging.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

Medtronic received additional information that the replaced battery's lot number is 0012177057.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: 19057725
• MDR Text Key: 339552115
• Report Number: 2184009-2024-00149
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2012
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2012
• 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