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

Model Number 560BCS1

Device Problems Battery Problem (2885); Material Deformation (2976)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

During preventive maintenance by a service technician it was noted that this bio-console 560 instrument had a battery cable damaged due to difficulties in removing the tray assembly from the base.This was detected during service so there was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was no reported issue with the battery or any other part of the system, the reported issues were identified during preventive maintenance.Additionally, the cable connects to the instruments power supply and system controller pcb.The damage occurred during removal of the base tray, and the unit was not powered on at that time.The damage to the cable did not fully pierce the insulation, the battery did not short to ground or any other part of the instrument.Medtronic received additional information that the base unit 560 cable assy ps is connected to the power supply, system controller and battery.That cable interconnects those components so power from the power supply can be sent to the system controller pcb and the system controller can send power to charge the battery.If the cable had been fully damaged, there would have been a potential for the battery to short to ground or to some other component since the cable carries battery power on it but the cable's insulation was still intact but visible abraded, so cable was replaced as a precaution.

Manufacturer Narrative

Device evaluation:during preventive maintenance by service technician on this bio console 560 instrument, due to difficulties in removing the tray assembly from the base, the battery cable was damaged.The issue was resolved by replacing the base unit 560 cable assy ps.Preventive maintenance was completed per specifications.Note:the instrument was not returned to medtronic facility but was serviced by field service technician.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: 17780251
• MDR Text Key: 323823682
• Report Number: 2184009-2023-00945
• Device Sequence Number: 1
• Product Code: DWA
• 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: 09/20/2023

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: Other
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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