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

Model Number	802018
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the flow sensor appeared to be fine.
Event or Problem Description
Upon receipt of the device, the user reported that the flow rate would not display.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) installed the flow pod into lab use only (luo) testing equipment.There was no flow displayed on the screen while the pod was in use.The information on the screen was consistent with what the user would see if there was no flow sensor attached.There were dashes displayed for the flow reading and a 'check sensor' message at the top of the screen.The pod consists of two printed circuit boards (pcb), a generic pcb and an application pcb.The generic pcb was replaced with a luo generic pcb and the issue remained, demonstrating that the issue originated on the application pcb.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Evaluation is progress, but not yet concluded.
Additional Manufacturer Narrative
Per supplier evaluation, the flow board was tested in verify mode and passed all testing.The board was fully functional and no issues were found.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: 18040020
• Report Number: 1828100-2023-00332
• Device Sequence Number: 17997057
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)220506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2024

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: 802018
• Device Catalogue Number: 802018
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 12/06/2023; 02/23/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/21/2023; 12/22/2023; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown