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

Model Number	803480
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After use of the device for a cardiopulmonary bypass (cpb) procedure, the user reported that the venous occluder went to closed and into calibration mode on its own.As mitigation, the user manually opened the venous occluder clamp and the surgery was completed without issue.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The field service representative (fsr) replaced the occluder module.The unit operated to manufacturer's specification.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per data log review: based on the system log, the occluder was calibrated on (b)(6) 2023 at 6:25am.At 7:26am the occluder was fully opened.The user changed the occluder percent flow from 100% to 35% and this was when the occluder stalled at 10:31:52.It was possible that calibration was performed without tubing installed, then the tubing was inserted at 7:26:52 when the occluder was fully opened, and since the occluder cannot move to closed position with tubing installed this caused it to stall.During laboratory analysis, the product surveillance technician (pst) installed the occluder module to lab use only (luo) testing equipment.The occluder module performed as expected throughout the evaluation when the occluder was properly loaded at calibration.It was determined that the occluder module met specification.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: 17216121
• Report Number: 1828100-2023-00180
• Device Sequence Number: 16899808
• Product Code: DTQ
• UDI-Device Identifier: 00886799000779
• UDI-Public: (01)00886799000779(11)210722
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 803480
• Device Catalogue Number: 803480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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