MAUDE Adverse Event Report: Perfusion Systems AFFINITY NT BALANCE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	511B
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction

• Brand Name: AFFINITY NT BALANCE
• Common Device Name: OXYGENATOR, 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 ; +353(091)708096
• MDR Report Key: 50926624
• Report Number: 2184009-2026-01409
• Device Sequence Number: 10735192
• Product Code: DTZ
• UDI-Device Identifier: 00763000187842
• UDI-Public: (01)00763000187842(17)271204(10)232828604
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K191444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 511B
• Device Catalogue Number: 511B
• Device Lot Number: 232828604
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 12/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown