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

Model Number	CDI753
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
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) did not maintain accurate values, including but not limited to the base excess (be) value which read 11 while the blood gas analyzer (bga) read the be as 0.As mitigation, the team used the bpm for the remainder of the case while drawing more frequent arterial blood gas (abg) and venous blood gas (vbg) labs.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: b3.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.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
Updated block: d9.
Additional Manufacturer Narrative
Updated blocks: h3 and h6.During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.The pst connected the blood parameter monitor (bpm) probe to lab use only (luo) testing equipment.The luo testing equipment found that the rt1 temperatures increased faster than the rt2, indicating that the thermistors were connected correctly.The temperature rose at the same rate as the temperature in the oven did.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint could not be 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: 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: 22977007
• Report Number: 1828100-2025-00222
• Device Sequence Number: 8937834
• Product Code: DRY
• UDI-Device Identifier: 00886799001899
• UDI-Public: (01)00886799001899(11)241209
• 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,Followup,Followup
• Report Date (Section B): 05/07/2026

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: CDI753
• Device Catalogue Number: CDI753
• 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: 09/11/2025; 11/07/2025; 01/14/2026; 03/24/2026; 05/06/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/25/2025; 02/04/2026; 04/16/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER.
• Patient Sex: Unknown