MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number	801188
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified the reported issue based on a video taken by the perfusionist.The fsr replaced the oxygen (o2) sensor and performed release testing.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the electronic patient gas system (epgs) fraction of inspired oxygen (fio2) was fluctuating.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: d9 and e1.Per data log review: based on the electronic patient gas system (epgs) log, there is a faulty oxygen (o2) sensor it failed calibration with a zero value, then it passes on the second attempt.This can make the o2 reading fluctuate.There are also multiple o2 sensor and blender disagree errors where the o2 sensor is reading a zero value.On (b)(6) 2025, the o2 sensor as replaced and reset to zero and the issue was resolved.Per the user facility, the unit was used until the end of the case.The display reading fluctuated, but the fraction of inspired oxygen (fio2) remained steady.An o2 tank was in the room if needed but was not used.The fsr replaced the o2 sensor on the pump and the issue resolved.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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 ; 7346634145
• MDR Report Key: 23397437
• Report Number: 1828100-2025-00265
• Device Sequence Number: 9946002
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 03/18/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/25/2025; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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