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	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fsr initially powered on the unit with no issue.The system was shut down and then attempted to be powered on via battery power, but the unit did not turn on.The unit was turned off and attempted to power back on via alternating current (ac) power, but the unit did not power up again.He attempted the other ccm port and the unit still did not power on.The fuse was checked and no issue was found.Another ccm was connected to the base and the ccm powered on normally indicating an issue with the initial ccm.The ccm was replaced.The unit operated to the manufacturer's specifications.
Event or Problem Description
The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the central control monitor (ccm) would not power on.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the central control monitor (ccm) to lab use only (luo) testing equipment.The ccm would not power up the display.The fuse within the power cable was checked and there were no issues.The 24 volts direct current (vdc), 5 vdc, and 3.3 vdc were all measuring within specification and there did not appear to be any issues with the local area network / interface board (lan/if).The suspected issue was a faulty display, but the results were inconclusive.The service repair technician (srt) found the ccm to not power on.He opened the ccm to check for loose connections; none were found.The lan/if board has power, as the leds light up when powered on.The issue was determined to be caused by a defective display, but since the part is unavailable, no repair will be done at this time.
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: 21946622
• Report Number: 1828100-2025-00091
• Device Sequence Number: 9122162
• Product Code: DTQ
• UDI-Device Identifier: 00886799001813
• UDI-Public: (01)00886799001813(11)240529
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: Other
• Device Model Number: 890500
• Device Catalogue Number: 890500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 08/26/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/11/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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