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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's territory manager, troubleshooting was done with the user facility.The system was powered down, then turned back on again.The data cable from the back of the module was disconnected, then reconnected.The data cable from the heart lung machine (hlm) base was disconnected, then reconnected.The issue remained after all troubleshooting attempts.All of the pins inside the cable and the ports were inspected and nothing appeared damaged.Per the manufacturer's field service representative (fsr), the loss of illumination appeared to be uniform across the entire display which is consistent with a failed local display.
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal control unit (ccu) display was missing pixels, and the letters were illegible and unable to be read.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: h3 and h6.The field service representative (fsr) replaced the centrifugal control unit (ccu) and completed release testing successfully.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
Updated block: d9.
Additional Manufacturer Narrative
Updated block: h6.The service repair technician (srt) found the display was defective and showing distorted images due to dead pixels.The display issue did not affect the functionality of the centrifugal control unit (ccu).The srt replaced the small graphics display and performed release testing.The unit operated to the manufacturer's specifications.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: 22251374
• Report Number: 1828100-2025-00140
• Device Sequence Number: 7850402
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)240918
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2026

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
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 09/29/2025; 01/19/2026
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/12/2025; 10/20/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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