MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560A

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

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 and external drive motor, it was reported the bio-console instrument started alarming and reading "motor malfunction" and the rpms increased to 6000+.Due to this, the cone decoupled.An attempt was made to turn the rpms down and then off using the control knob, however, rpms remained over 6000.Rpms slowly came down to 960 on their own with the knob still in the off position.The patient was clamped out, the cone was reseated, and the customer tried to re-establish flows.Rpms increased back up to 6000 with no flow to the patient.Electronic connections were checked, the bio-console was powered off, and the customer simultaneously started hand cranking.Cath lab paged perfusion back-up, a new bio-console and external drive motor were brought into the room.The cone was switched to new external drive motor, attached to the new bio-console.Flows were reestablished to 4 lpm at 2880 rpms.The customer continued to work throughout incident, the lowest patient mean arterial pressure (map) was 45.The patient lost pulsatility for 60 seconds, but remained stable after reinitiating of flow.

Manufacturer Narrative

Conclusion: complaint confirmed for the bio-console instrument's alarm and increase in rpm.The issue was verified during service, as medtronic service noted error 47 (sc mpu mc hall phase a soft error) and error 52 (sc mpu mc speed control gain soft error) in the error logs, however, the issue was not duplicated during service.The mp module was replaced as a precaution to address the issue.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.

Manufacturer Narrative

Device evaluation summary: the reported rpm issue with the external motor drive was not verified during service.The service technician was unable duplicate the issue during service.The service technician ran unit with flow loop at 2500rpms at 4lpms for 45 minutes without errors.While running at 2500rpms and 4lpm,the service technician wiggled the motor cable along its length, no change in rpms or motor function.The service technician tapped and shook the motor and there was no change in rpms or motor function.The service technician inspected cable for cuts and abrasions, no damage to cable was found.Preventive maintenance was performed per specifications.Additional information: medtronic received additional information that affinity centrifugal pump cone was also used during the procedure.The cone was not replaced during the error as it did not appear to be the cause of the error.The cone continued to operate as normal once the console and motor were replaced.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: MOTOR EXTERNAL DRIVE
• 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: 14487968
• MDR Text Key: 292498146
• Report Number: 2184009-2022-00115
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994647832
• UDI-Public: 00613994647832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

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: 560A
• Device Catalogue Number: 560A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 07/25/2022
• Supplement Dates FDA Received: 07/20/2022; 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 87 KG