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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's biomedical engineer, the uas worked as intended during priming.The roller pump appropriately stopped due to the uas alarming as a safety response.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the ultrasonic air sensor (uas) started alarming once blood reached the air bubble detector (abd).As mitigation, the uas was turned off for the remainder of the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: d9.
Additional Manufacturer Narrative
Updated blocks: h3 and h6.During laboratory evaluation, the product surveillance technician (pst) duplicated the reported issue.The air bubble detector (abd) was evaluated using a lab use only (luo) testing equipment.After the circuit was set up and the abd activated from the ccm it immediately started alarming.There was no air in the circuit, and it was alarming and unable to clear the alarm.The pst had to shut off the abd and reactivate to clear, but it would immediately alarm again.It was determined that the abd did not operate as intended.
Additional Manufacturer Narrative
Updated block: h6.Per supplier evaluation, the sensor was falsely alarming for air because the power cable was not completely secure and was causing an intermittent connection while the sensor was moving/handled.The power cable was likely not fully secured during assembly, but the sensor was able to pass all testing at the supplier because the failure only presented itself while the sensor was moving around.The power cable was fully secured and then retested.The sensor then passed all bubble testing.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: 21775888
• Report Number: 1828100-2025-00073
• Device Sequence Number: 15512869
• Product Code: DTQ
• UDI-Device Identifier: 00886799000038
• UDI-Public: (01)00886799000038(11)250106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2025

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?: 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 04/30/2025; 08/26/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/23/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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