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

Model Number	5773
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's biomedical engineer, the abd was tested and a one cubic centimeter (cc) bubble was able to pass through two of the five times it was tested.It was observed that the abd sensor wall had residue on it and it was cleaned with alcohol.The abd was retested and the issue was resolved.The field service representative (fsr) could not duplicate the reported complaint.Functional/release testing was performed.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 air bubble detector (abd) failed to detect an air bubble in the arterial line.It was reported that the air bubble reached the patient, however no further details regarding any harm to the patient were provided.There were no reported consequences to the patient.No other details regarding the nature of this event were provided.
Additional Manufacturer Narrative
Updated blocks: b3, b5, e1, and h6.Per data log review: there was a false alarm on (b)(6) 2026.A false alarm means that the sensor triggered an alarm without detecting any fluid.According to additional information, the user could not duplicate the issue.Based on the logs, there were no errors, just routine air alarm detected.There were no observed issues with the abd.
Event or Problem Description
Additional information was received that the surgical procedure was completed successfully.There was no delay.There was an estimated blood loss for the whole case of 2700 milliliters (ml) that occurred during the case, prior to the issue with the air bubble detector (abd).It was stated that the blood loss was not related to the reported abd issue.The patient had bleeding in the lung that needed to be patched and while doing that, the surgeon also nicked the aorta and caused bleeding from that.This occurred off bypass and the abd issues occurred after reinitiation of bypass.Testing did not find air and the patient woke up and was talking and functioning as normal.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint could not be 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: 24501666
• Report Number: 1828100-2026-00034
• Device Sequence Number: 21317966
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 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): 05/07/2026

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: 5773
• Device Catalogue Number: 5773
• Was Device Available for Evaluation?: Yes
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 05/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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