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

Model Number 560BCS1

Device Problem Device Alarm System (1012)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported error message 'pressure monitor 1/2 malfunction' and error 25(sc mpu fs coil driver monitor low hard error) and 65( sc mpu pm ref 2 gain hard error) were verified during service.The service technician found the log where errors 25 and 65 occurred repeatedly and found that the voltage value of a/d converter was out of range.The issue was resolved by performing voltage calibration on the a/d converter part of the sc board.After the a/d converter calibration was completed, it was confirmed that the errors 25 and 65 were not reproduced in the test.The burn-in test was performed by service technician according to the customer's environment (2500rpm, 3hr), but the symptoms were not reproduced.The customer was notified upon completion of the service and the instrument was returned to the customer for use.Preventive maintenance was performed per specifications.D9: instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center.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.

Event Description

Medtronic received information that during use of a bio-console base and external drive motor, it was reported that the customer observed a error message 'pressure monitor 1/2 malfunction'. the instruments were replaced to complete the procedure.There was no patient impact associated with this event.Additional information received that hand crank was not used.Error 25(sc mpu fs coil driver monitor low hard error) and 65( sc mpu pm ref 2 gain hard error) occurred.It was also reported that the service technician found that the voltage value of a/d converter was out of range.

Manufacturer Narrative

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: 16021268
• MDR Text Key: 308205276
• Report Number: 2184009-2022-00445
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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