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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal control unit (ccu) had no forward flow.The team open and closed the flow sensor and the issue remained.The centrifugal head was checked and found to be seated properly within the drive motor.The clinician started to hand crank when the team placed the centrifugal head back into the drive motor again and the issue was resolved.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The field service representative (fsr) found that per the data log review, the ccu was off at the time of the incident which would cause no flow.There was nothing in the log data to indicate there was any issue that might have triggered the pump to stop, it would have been due to user interaction with the ccu.The ccu, centrifugal motor, and flow meter passed functional testing.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
Updated blocks: b1, b2 and b5.Per data log review: there were no errors logged.The pump started and stopped based on user command, and there were no motor errors or any internal triggers that would cause an alarm.The log is based on 24 hours and the ccu had no indications of a faulty ccu or motor.
Event or Problem Description
Per clinical review: on (b)(6) 2024, the team experienced a problem with their centrifugal control unit (ccu) during cardiopulmonary bypass (cpb) whereby no forward flow was established.The pump was primed normally, but when the clinician went to initiate cpb, they had no forward flow.The user felt that they had revolutions per minute (rpms) but still no forward flow.The team checked the seating of the centrifugal head within the drive motor.The clinician opted to hand crank.Thereafter, the team placed the centrifugal head back into the drive motor and the issue resolved.The ccu log was reviewed and there were no logged errors indicating the pump was not behaving normally.The pump started and stopped based on user command.The procedure was completed successfully with no delay, no blood loss, and no adverse event.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was 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: 20562006
• Report Number: 1828100-2024-00302
• Device Sequence Number: 18364268
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)210107
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/26/2025

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: 10/04/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 02/07/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/13/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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