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

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	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility, the patient's arterial blood gas (abg) was taken once on cpb, and an in vivo calibration was performed.Subsequent abg/ venous blood gas (vbg)s were taken, and the k+ and co2 values were not in alignment with the abg/ vbg readings.In a picture provided to the manufacturer, the temperature reading was 24.5 degrees celsius (c), k+ 5.4 millimoles per liter (mmol/l), and co2 45 millimeters of mercury (mmhg).The patient temperature was actually 37 degrees c according to the hlm, with a k+ of 3.6 mmol/l, and co2 of 67.2 mmhg.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) thermistor demonstrated a significant difference from that of the patient's temperature noted on the heart lung machine (hlm).It was determined that the potassium (k+) and the carbon dioxide (co2) values were also inaccurate when compared to the blood gas analyzer (bga).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2025, the team experienced a problem with their bpm during cpb whereby the temperature measurement from the bpm thermistor demonstrated a significant difference from that of the patient's temperature noted on the hlm.The patient's temperature was reading 37 degrees on the hlm while the temperature value on the bpm was reading 24.5 degrees.The clinician was concerned with the wide variation in the bpm oneview temperature compared the bpm 550.The clinician did not use this temperature in their decision making as advised that the instruction for use (ifu) states it is not meant to reflect patient temperature.It was determined that the cause of failure was due to incorrectly wired dual thermistor leads (lead wires were soldered to the wrong location).Although the thermistors were operating correctly, this caused the temperature reading of the bpm probe to be inaccurate due to the switched inputs of the two thermistors.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 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: CDI ONEVIEW MONITORING SYSTEM
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI ONEVIEW MONITORING
• 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: 22075393
• Report Number: 1828100-2025-00110
• Device Sequence Number: 8711355
• Product Code: DRY
• UDI-Device Identifier: 00886799001899
• UDI-Public: (01)00886799001899(11)240814
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 07/08/2025

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: CDI753
• Device Catalogue Number: CDI753
• Was Device Available for Evaluation?: Yes
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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-2018-2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER
• Patient Sex: Unknown