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

Model Number 560BCS1

Device Problems Battery Problem (2885); Power Problem (3010)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the battery would not power and the ac power needed to be removed.The use of the instrument was unspecified.There was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic received additional information that the instrument had been in use for nearly 10 years and the battery is original.Device evaluation summary: the reported issue that the battery would not power and the ac power needed to be removed was verified during service.During preliminary analysis there was a battery charge failure.Service technician stated that the fault was the battery.The issue will be resolved by replacing the battery.Preventative maintenance will be performed per specifications.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: 19070424
• MDR Text Key: 339704929
• Report Number: 2184009-2024-00162
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00643169315822
• UDI-Public: 00643169315822
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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