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

Model Number	CDI754
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	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) venous saturation was reading 100 when it should have been reading 83 post first in vivo.A second in vivo was performed and the venous saturation was accurate.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Per the manufacturer's territory manager, the blood parameter monitor (bpm) probes were replaced.
Additional Manufacturer Narrative
If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: on (b)(6) 2024 the team at the user facility experienced a problem with the blood parameter monitor (bpm) while on cardiopulmonary bypass, whereby there were intermittent venous and saturation values 100 venous sat post first in-vivo at 83.This complaint is related to an issue where the threshold value in the signal filter implemented in the hematocrit saturation (h/s) software was set below the level of electronic noise, resulting in a threshold too restrictive for normal signal variation in a clinical setting.This was causing the h/s saturation of oxygen (so2) value to appear as dashes intermittently.The device was not changed out.There was no delay, no blood loss, and the surgery was completed successfully with no adverse event.
Additional Manufacturer Narrative
Updated blocks: h6 and h9.The service repair technician (srt) upgraded the device from v1.1 to v1.2.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: 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: 21124113
• Report Number: 1828100-2025-00004
• Device Sequence Number: 12951948
• Product Code: DRY
• UDI-Device Identifier: 00886799001882
• UDI-Public: (01)00886799001882(11)240724
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/23/2025

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: CDI754
• Device Catalogue Number: CDI754
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/17/2025; 03/07/2025; 03/31/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/10/2025; 03/31/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1492-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown