MAUDE Adverse Event Report: PERFUSION SYSTEMS PERFORMER CPB SUPPORT SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY B

Model Number	R5100052
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note on d9/h3: the event occurred during preventative maintenance by a medtronic field service technician.The device was not returned to medtronic for analysis.Conclusion: complaint confirmed for the motor of the performer randomly starting to spin by itself at a speed <(><<)>500 rpm for one/two seconds even when the control potentiometer was in the "off/detent" position (motor fully stopped) as identified during preventive maintenance.As a precaution, the service technician stopped the preventive maintenance and the instrument has been placed out of order and the customer has been informed to not use the instrument.There is no allegation against the eternal drive motor, the issue was related to the speed control circuit.This occurrence was identified during preventive maintenance, therefore, there was no patient involvement.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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 or Problem Description
During preventive maintenance of this performer instrument, the service technician noticed an issue on the rpm control of the external drive motor.The service technician observed that the motor randomly started to spin by itself at a speed <(><<)>500 rpm for one/two seconds even when the control potentiometer was in the "off/detent" position (motor fully stopped).The technician observed that this issue happened two to three times in a row and for the rest of the time, the motor remained steady to zero rpm.As a precaution, the service technician stopped the preventive maintenance and the instrument has been placed out of order and the customer has been informed to not use the instrument.This was detected during service so there was no adverse patient effect.Additional information received confirmed that there is no allegation against the eternal drive motor, the issue is related to the speed control circuit.

• Brand Name: PERFORMER CPB SUPPORT SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY B
• 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: 17350947
• Report Number: 2184009-2023-00837
• Device Sequence Number: 5206038
• Product Code: DTQ
• UDI-Device Identifier: 00885074514857
• UDI-Public: 00885074514857
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K052555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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
• Operator of Device: Other
• Device Model Number: R5100052
• Device Catalogue Number: R5100052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown