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

Model Number	816300
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the central control monitor (ccm) mouse on the touchscreen was off about half of an inch.Recalibration worked for a while, then it drifted again an inch off but was able to be recalibrated again and drifted again.There was no patient involvement.
Additional Manufacturer Narrative
The fsr replaced the ccm and performed release testing.The unit operated to the manufacturer's specifications.

• 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: 50773105
• Report Number: 1828100-2026-00268
• Device Sequence Number: 16105831
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)220113
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: Other
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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