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

Model Number	R5100052
Medical Device Problem Codes	Device Alarm System (1012); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the reported issues of the instrument would not prime, and it displayed a possible error message of "pump stopped" were verified during field service.During service the technician noted that when turning on the instrument the motor would spin during the self-test.The technician pressed the start button for the pm4 which did not work.The technician then swapped the connectors on the sin-ui board, and they were able to turn the motor on with a pm2's start button while pm2 itself would not start with pm4's start button.The issues were resolved by replacing the overlay for pm4.Post-repair testing was performed per specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that prior to use of this performer instrument, the customer noticed that the instrument would not prime and it displayed a possible error message of "pump stopped".The instrument was changed out with a backup and there was no reported adverse patient effect.Additional information received confirms the hand crank was not required to maintain flow.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13575981
• Report Number: 2184009-2022-00016
• Device Sequence Number: 5681007
• Product Code: DTQ
• UDI-Device Identifier: 00885074514857
• UDI-Public: 00885074514857
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: Health Professional
• 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: 01/27/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2008
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown