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

Model Number	889773
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon receipt of the device, the oxygen (o2) sensor failed calibration.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory evaluation, the product surveillance technician (pst) connected the electronic patient gas system (epgs) to lab use only (luo) testing equipment.The epgs failed calibration.The o2 sensor was allowed to equilibrate to ambient oxygen in the room and the expected output was 9 - 13 millivolts (mv) but the sensor measured 8.8 mv.The o2 sensor was replaced with a luo o2 sensor which measured 11.3 mv in ambient air.Calibration was successful and the epgs maintained a steady and accurate o2 blend for an hour following calibration.It was determined the o2 sensor was reading too low and did not operate as intended.This complaint is related to (b)(4)/ mfr# 1828100-2024-00045.A second complaint was determined to be created for the newly installed o2 sensor once the sensor failed calibration, the output voltage was found to be low, and the epgs successfully passed calibration with a luo o2 sensor.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 reported complaint was confirmed.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 rd; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18766227
• Report Number: 1828100-2024-00065
• Device Sequence Number: 20758455
• Product Code: DTQ
• UDI-Device Identifier: 04250320600725
• UDI-Public: (01)04250320600725(11)231017(17)250417
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: Other
• Device Expiration Date: 04/17/2025
• Device Model Number: 889773
• Device Catalogue Number: 889773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown