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

Model Number 560BCS1

Device Problems Device Alarm System (1012); Obstruction of Flow (2423); Connection Problem (2900); Pumping Problem (3016)

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

Event Date 06/14/2022

Event Type  Injury  

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.

Event Description

Medtronic received information that during use of a bio-console instrument, it was reported that when the instrument was running, the motor suddenly stopped and a fault code 054 appeared.There was no patient impact associated with this event.Medtronic received additional information stating that the customer checked the instrument and found that there was no continuity in the pins (h,g,f) of the user interface (ui) to the base unit (bu) cable connectors.The customer stated that this caused the error.Medtronic received additional information that there was no visual, audible, or performance abnormalities with the external drive mo tor/pump.The flow to the patient was impacted and addressed by changing to another bio-console instrument.The customer stated that the error/warning message was addressed by using a dmm to check the rpm control bias voltages and change the m/p pcb.There was no safety systems in use (level sensor, bubble detector, and autoclamp).

Manufacturer Narrative

Additional information b5: medtronic received additional information that dmm stands for fluke 87 or equivalent.The hand crank was required to maintain flow during instrument swap out.The hand crank was in use for an hour.Product analysis: the reported issues of the motor suddenly stopped and a fault code 054 appeared were verified during service.The issue will resolved by replacing the cable 560 user interface assy.Post-repair testing will be performed per specifications.The instrument was analyzed by a field service technician within the facility.The instrument did not return to medtronic for analysis/service.Conclusion: the complaint was confirmed for the bio-console instrument's reported error code 054.The issue was verified via the cus tomer-provided photo.Review of this instrument's service history record found no abnormalities during service that would cause or contribute to the reported event.Trends for issues with this product are reviewed at quarterly quality meetings.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: 14998615
• MDR Text Key: 302791161
• Report Number: 2184009-2022-00168
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: 00613994450463
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 85 KG