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

Model Number	816572
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal motor stopped working in the middle of the case and the team had to hand crank for three minutes and then the heart lung machine (hlm) was switched out for another machine.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences of the patient.
Additional Manufacturer Narrative
The field service representative (fsr) could not duplicate the reported complaint.A review of the data log indicated that the system was behaving as expected, and no issues were found.There was an air bubble detector (abd) alarm that went off, and the safety connections caused the centrifugal motor to stop.The abd alarm was not cleared until the case ended (and the system was swapped out), thus the centrifugal was unable to start while the abd alarm was still active.The centrifugal system, flow sensor, and abd successfully passed testing.The unit operated to the manufacturer's specifications.The part number (pn), serial number (sn), and udi of the abd are: pn: 5773, sn: (b)(6), udi: (b)(4).
Event or Problem Description
Per clinical review: on 28jul2025, the team at the user facility experienced a problem with their centrifugal controller unit (ccu) during cardiopulmonary bypass whereby the centrifugal motor stopped working.As a result, a hand crank was used for approximately 3 minutes, ultimately changed out for a different system.The data logs indicated that the system was behaving as expected.There was an air bubble detector (abd) alarm that went off, and the safety connections caused the centrifugal motor to stop as configured.The abd alarm wasn¿t cleared until the case ended (and system was swapped out), and thus the centrifugal motor was unable to start while the abd alarm was active.There was no delay, no blood loss, and the surgery was completed successfully.
Additional Manufacturer Narrative
Updated blocks: b1, b2, and b5.
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: 22854048
• Report Number: 1828100-2025-00204
• Device Sequence Number: 11866939
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)210419
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Device Lot Number: 1928
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 12/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/28/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown