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

Model Number	816572
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal control unit (ccu) displayed an 'arterial service pump' message.As mitigation, the team used a roller pump in place of the centrifugal.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) observed damage on the centrifugal control unit (ccu) cover.During troubleshooting the error message appeared, and he also noted a burning odor.The cover was removed, and the ribbon cable was hot to the touch along with dark residue found inside the cover.The ccu was replaced.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
Updated block: d9 during laboratory analysis, the product surveillance technician (pst) connected the centrifugal control unit (ccu) to lab use only (luo) testing equipment.Upon visual inspection, the pst observed multiple areas with housing damage and broken pieces of the housing inside the unit.All the printed circuit boards (pcb) were inspected for any evidence of a short circuit condition, which was not observed, but the pst found that the cable between the display subassembly and the application pcb was disconnected.Initially when the ccu was started, there was no display output due to the disconnected cable.After the pst reconnected the cable, the centrifugal pump was set to spin at a constant rate for two hours with no issues observed.The unit was then configured to run in pulsatile mode and ran for two more hours with no issues observed.The data log did indicate display supply errors.It was determined that the ccu did not meet specification.
Additional Manufacturer Narrative
The service repair technician (srt) confirmed that the centrifugal control unit (ccu) was received opened, with the cable disconnected, and screws not securely fastened which would cause the ccu to exhibit errors.He replaced the display.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: 18347291
• Report Number: 1828100-2023-00374
• Device Sequence Number: 15005533
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)180514
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup
• Report Date (Section B): 03/07/2024

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: 816572
• Device Catalogue Number: 816572
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/28/2023; 02/14/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/03/2024; 01/19/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2018
• 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