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	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility, there were no high pressure or retrograde flow alarms on the pump, and it was possibly a high-pressure excursion (hpe) event with the patient.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal control unit (ccu) did not produce forward flow despite showing 3,000 revolutions per minute (rpms) on the monitor.As mitigation, the team came off bypass and then went back on with the same circuit after 10 minutes and it worked fine.The surgical procedure was completed successfully.There was a 10-minute delay.There was no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The field service representative (fsr) could not duplicate the reported complaint.The centrifugal and flow systems were release tested, and the issue is believed to have been due to a high-pressure excursion (hpe) event with the patient.The unit operated to the manufacturer's specifications.
Event or Problem Description
Per clinical review: on (b)(6) 2024, the team at the user facility experienced a problem with their centrifugal control unit during an adult cardiopulmonary bypass procedure whereby the unit could not produce forward flow despite showing 3000 revolutions per minute (rpms) on the monitor.No high pressure or retrograde flow alarms went off on the pump, so the team was not sure what happened.It was thought to have possibly been a high pressure excursion event with the patient.The team opted to come off bypass and after 10 minutes, they tried again on the same circuit, and it worked fine.
Additional Manufacturer Narrative
Updated blocks: 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: 20157116
• Report Number: 1828100-2024-00248
• Device Sequence Number: 4209521
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)200226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/13/2025

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
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/08/2024; 10/30/2024; 12/20/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/01/2024; 11/20/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown