MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI ONEVIEW MONITORING SYSTEM; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI ONEVIEW

Model Number	CDI763
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the perfusionist, the flow captured from the heart lung machine (hlm) was reading around 6.0 liters per minute (l/min) but the flow from the bpm flow sensor was variable from 2.0 to 6.5 l/min.Per the manufacturer's clinical specialist, the perfusionist stated there was no manipulation at the field or any visible changes to explain the variable flow from the flow reading, as no changes were present.It was explained that the bpm flow can read a new flow every 10 milliseconds and display a new reading on the monitor every second.Additionally, there can be some allowable variance of a flow probe so there can be some discrepancies in flow between sensors and still be accurate.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) flow sensor was variable from 2.0 to 6.5 liters per minute (l/min).As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: d9.
Additional Manufacturer Narrative
Updated blocks: h3 and h6.Per the supplier evaluation, the pump was set to 2.50 liters per minute (l/min) and the sensor was reading 3.56-3.61 l/min.When set to 3.50 l/min, the sensor read 4.65-4.68 l/min, and when set to 5.00 l/min the sensor read 6.21-6.27 l/min.The sensor was found to have a defective channel 2 with an extremely high standard deviation.A visual inspection of the sensor was performed, noting a few minor marks, indicating the potential that the sensor may have been dropped by the user.This could have caused damage to the ceramic, which would not lead to immediate failure but could result in the very significant measurement deviations.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: CDI ONEVIEW MONITORING SYSTEM
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI ONEVIEW
• 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: 22973929
• Report Number: 1828100-2025-00221
• Device Sequence Number: 8938211
• Product Code: DRY
• UDI-Device Identifier: 00886799001950
• UDI-Public: (01)00886799001950(11)250327
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K234065
• 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): 01/06/2026

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: CDI763
• Device Catalogue Number: CDI763
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 12/09/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/03/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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