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

Model Number	890500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) ran testing on the ccm and could not duplicate the reported complaint.The fsr replaced the ccm.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that the central control monitor (ccm) displayed a 'system computer needs service' message multiple times.There was no blood loss, nor adverse consequences to the patient.No other details regarding the nature of this event were provided.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Additional information was received that the issue occurred during cardiopulmonary bypass (cpb).There was no delay.The surgical procedure was not completed successfully as the patient passed away.It was reported that the alleged malfunction of the central control monitor (ccm) was not related to the death of the patient.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The service repair technician (srt) could not duplicate the reported complaint.The central control monitor (ccm) booted up as expected with no issues.The ccm local area network interface (lan/if) board was replaced as a precaution.Release testing was performed.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: 20549099
• Report Number: 1828100-2024-00300
• Device Sequence Number: 7481359
• Product Code: DTQ
• UDI-Device Identifier: 00886799001813
• UDI-Public: (01)00886799001813(11)231128
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 05/13/2025

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: 890500
• Device Catalogue Number: 890500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 04/22/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/03/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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