CDI OneView Monitoring SystemRecalls & reported problems across all models

We found 3 models of CDI OneView Monitoring System by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2025 and Sep 5, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CDI OneView Monitoring System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 3, 2025Class IIOpen, Classified

   During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

   Z-1492-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported CDI OneView Monitoring System problems

CDI OneView Monitoring System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CDI OneView™ Monitoring System CDI754

  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
  1 recall1 report
• CDI OneView™ Monitoring System CDI753

  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
  4 reports
• CDI OneView™ Monitoring System CDI763

  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
  1 report

Recent CDI OneView Monitoring System adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977007 ↗
• MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973929 ↗
• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB), THE BLOOD PARAMETER MONITOR (BPM) PARTIAL CARBON DIOXIDE (PCO2) VALUE WAS LESS ACCURATE THAN EXPECTED. AFTER THE FIRST OR SECOND IN VIVO CALIBRATION, THE VALUE SEEMED TO CORRELATE BETTER ALONG WITH THE BLOOD GAS ANALYZER. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079317 ↗
• MalfunctionMay 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075393 ↗
• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856959 ↗
• MalfunctionJan 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124113 ↗

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