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	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified the reported complaint through data log review but was unable to duplicate or find any failure.All cables and connections were inspected and tightened.Release testing was performed.The issue reoccurred on another date and the perfusionist indicated that the problem was happening when the level alarm was activated.The fsr was able to duplicate this with the level alarm, the air sensor alarm, and by starting and stopping the pump with the local display on the ccu.He replaced the ccu and the centrifugal drive motor.The unit operated to the manufacturer's specifications.The product information of the centrifugal drive motor that was replaced is: part number: 164267, serial number: (b)(6), udi: (b)(4).
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal control unit (ccu) had an intermittent problem where the display was blinking and then it restarted itself.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a delay of an unknown amount.There was no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The service repair technician (srt) could not duplicate the reported complaint.The centrifugal control unit (ccu) was run in pulse mode overnight for a total of 16 hours with no rebooting or blinking of the display screen observed.The srt did observe some corrosion on the external cable assembly where the cable connects to the ccu that could cause a connection issue.The ccu was booted up multiple times with no observed issues.The unit was opened to check for loose connections, and none were observed.The srt replaced the display to pump cable and the external cable assembly as a precaution.The unit operated to the manufacturer's specifications.
Event or Problem Description
Per clinical review: on (b)(6) 2025, the team at the user facility experienced a problem with the heart lung machine during cardiopulmonary bypass whereby the centrifugal control unit display was blinking.They continued to use the device to complete the case as the information was available on the central control monitor (ccm).The procedure was completed successfully with no delay, no blood loss, and no adverse event.
Additional Manufacturer Narrative
Updated blocks: b5 & h6.The reported complaint was confirmed; however, the field service representative (fsr) and service repair technician (srt) were not able to duplicate the reported complaint.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: 23096655
• Report Number: 1828100-2025-00233
• Device Sequence Number: 8618028
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)240520
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/16/2025

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: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 11/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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