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 03/14/2024

Event Type  malfunction  

Event Description

During preventive maintenance by a service technician this bio-console 560 instrument had the batteries leaking.This was detected during service so there was no patient involvement, so no adverse effect occurred.Medtronic received additional information that batteries had been installed in the instrument for less than a year, and never met its life span.The lot number of the batteries removed from the instrument is 0011780938.

Manufacturer Narrative

Device evaluation:during preventive maintenance by service technician, it was observed that the bio-console 560 instrument had a battery leakage.The issue was resolved by replacing the battery,12v,6.5 ah ,certified.Preventive maintenance was completed per specifications.Note the instrument was not returned to medtronic facility but was serviced by field service technician.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: 19069266
• MDR Text Key: 340467941
• Report Number: 2184009-2024-00158
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• 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