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	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified the reported complaint.The occluder head was replaced and release testing was performed.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the occluder had calibration issues, the piston was not moving, and it was hot to the touch.As mitigation, the tubing was removed from the occluder and the case was completed without it.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team experienced an issue with their heart lung machine (hlm) during cpb.Specifically, while performing the pre-bypass checklist the user noted that the venous occluder head was hot to touch.Additionally, there were issues with calibration and the occluder piston was not moving.The user took the venous tubing out of the occluder and proceeded without it.There were no delays to the procedure and no blood loss noted.The case finished without incident.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) connected the occluder head to lab use only (luo) testing equipment.During evaluation of the occluder head the pst observed that the housing exhibited elevated temperatures.The occluder printed circuit board (pcb) diodes at d1 and d2 were observed to be overheated when the occluder head was disassembled.The pst also attempted occluder calibration which initially passed but then requested a new calibration.It was determined that the occluder head did not meet 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: 17624964
• Report Number: 1828100-2023-00254
• Device Sequence Number: 17676227
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)220716
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 10/30/2023

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: 806455
• Device Catalogue Number: 806455
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 10/17/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown