MAUDE Adverse Event Report: Terumo Cardiovascular Systems Corporation Advanced Perfusion System 1; Console, Heart-Lung Machine, Cardiopulmonary Bypass-Advanced Perfusion System 1

Model Number	816571
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction

• Brand Name: Advanced Perfusion System 1
• Common Device Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass-Advanced Perfusion System 1
• Manufacturer (Section D): Terumo Cardiovascular Systems Corporation; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): Same
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; +1(734)663-4145
• MDR Report Key: 50508241
• Report Number: 1828100-2026-00232
• Device Sequence Number: 10087859
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)171201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2017
• 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