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

Model Number	806455
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fsr replaced the occluder head and performed release testing.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 occluder head was not clamping down all the way.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the occluder head to lab use only (luo) testing equipment.The occluder was set up and calibrated with 3/8-inch tubing installed.Water was added to the tubing and when the occluder was fully closed it was slowly allowing water drops to pass through.The whole system was shut down, restarted and calibrated again.The same test was run and this time there was no water that passed through, and the issue was not repeatable.
Additional Manufacturer Narrative
The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint.Preventative maintenance and verification testing was completed.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: 21154056
• Report Number: 1828100-2025-00010
• Device Sequence Number: 15727733
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)180709
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 806455
• Device Catalogue Number: 806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/28/2025; 05/01/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/20/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2018
• 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