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	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During field installation of the device, the user reported that the air bubble detector (abd) kept alarming even when there were no air bubbles present.The module and the cord were replaced, but the issue remained.The abd sensor was swapped with an abd sensor from a different machine and the issue was resolved.There was no patient involvement.
Additional Manufacturer Narrative
The field service representative (fsr) confirmed that the abd sensor was constantly alarming even when there were no air bubbles.She replaced the abd sensor and completed functional testing.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the air bubble detector (abd) to lab use only (luo) testing equipment.After the circuit was set up and the abd activated from the central control monitor (ccm), the abd instantly started alarming.The abd was activated multiple times and each time it would immediately alarm.It was determined that the abd did not meet specification.

• 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: 22535624
• Report Number: 1828100-2025-00170
• Device Sequence Number: 15325401
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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
• Date Returned to Manufacturer: 07/01/2025
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/02/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/11/2025; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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