CDI OneView™ Monitoring System CDI753Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886799001899), received between Apr 17, 2025 and Sep 5, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K234065); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K234065. One submission often covers many models, so check the product and lot details in each record.

• Z-2018-2025 · May 28, 2025 · Open, Classified
  CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
• Z-1492-2025 · Mar 3, 2025 · Open, Classified
  Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754