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	03/24/2025
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) potassium (k+) reading drifted off from the in vivo value.The issue was mitigated by taking additional blood gas samples.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: on (b)(6) 2025, the team at the user facility experienced a problem with their blood parameter monitor (bpm) during cardiopulmonary bypass whereby the potassium (k+) value drifted off from the in-vivo.The users mitigated this issue by doing additional lab samples.There are two thermistors on the bpm probe, the first is to measure the shunt sensor blood temperature, the other is to measure non-blood temperatures and compensate for ambient thermal factors in the final calculated shunt 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.Since temperature is an input to the calculating algorithms for other parameters, those may also be inaccurate.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.
Additional Manufacturer Narrative
Updated blocks: h6 and h9.The reported complaint was confirmed.During investigation, it was determined that the cause of the issue was incorrectly wired dual thermistor leads.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: 21856959
• Report Number: 1828100-2025-00079
• Device Sequence Number: 20007528
• Product Code: DRY
• UDI-Device Identifier: 00886799001899
• UDI-Public: (01)00886799001899(11)240918
• 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
• Report Date (Section B): 08/27/2025

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?: 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: 03/24/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 08/13/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/13/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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
• Patient Sex: Unknown