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	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a non-clinical activity, the central control monitor (ccm) touchscreen was out of calibration.The user facility attempted a recalibration and the arrow on the display went missing causing the ccm to be unusable.There was no patient involvement.
Additional Manufacturer Narrative
The field service representative (fsr) verified the reported complaint finding that the ccm cursor was too far off from the touch screen location.The fsr replaced the ccm and completed release testing.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the central control monitor (ccm) to lab use only (luo) testing equipment.After completing the boot sequence, none of the home screen options could be accessed.Attempting to touch the screen over one of the options resulted in no visible cursor.When the screen was touched in the bottom left, the cursor appeared in the top right.Touching the screen in the bottom right caused the cursor to appear in the top left.After recalibrating the screen, the issue remained.The ccm did not operate as intended.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
The service repair technician (srt) was able to successfully enter the calibration screen, however, attempting to access the tabs was unsuccessful due to erratic cursor movements.It was determined that the display did not meet specification.
Additional Manufacturer Narrative
Per supplier evaluation, functional testing was completed on the central control monitor (ccm) and found that the touch controller was damaged and nonfunctional.There were multiple different possible root causes described including environmental factors, power fluctuations, physical damage, static electricity or other electrical failures.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: 19067640
• Report Number: 1828100-2024-00112
• Device Sequence Number: 6593277
• Product Code: DTQ
• UDI-Device Identifier: 00886799001813
• UDI-Public: (01)00886799001813(11)231024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/13/2024

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: 890500
• Device Catalogue Number: 890500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/13/2024; 08/22/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/01/2024; 06/04/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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