CDI Blood Parameter Monitoring System 500Recalls & reported problems across all models
Terumo Cardiovascular Systems Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of CDI Blood Parameter Monitoring System 500 by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2018 and Dec 18, 2025 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (27 reports).
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
Reports received per month, all models
Most reported CDI Blood Parameter Monitoring System 500 problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings27
- Electrical /Electronic Property Problem4
- Incorrect Measurement3
- Smoking3
- Degraded1
- Sparking1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient18
- No Patient Involvement3
- Insufficient Information2
CDI Blood Parameter Monitoring System 500 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CDI™ Blood Parameter Monitoring System 500 500AHCTMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass27 reports
- CDI™ Blood Parameter Monitoring System 500 500AVHCTMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass12 reports
Recent CDI Blood Parameter Monitoring System 500 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 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) HEMATOCRIT (HCT) AND HEMOGLOBIN (HGB) VALUES WERE INACCURATE. AS MITIGATION, THE TEAM DISCONNECTED THE BPM, POWER CYCLED THE UNIT, AND RECALIBRATED. 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 23838796 ↗MalfunctionSep 10, 2024Incorrect, 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) POTASSIUM (K+) VALUE DRIFTED EVEN THOUGH K+ WAS NOT GIVEN. AS MITIGATION, MANUAL BLOOD GASES WERE DONE, AND THE BPM WAS RECALIBRATED MID-CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ON 20AUG2024, THE TEAM EXPERIENCED A PROBLEM WITH THE BPM DURING CPB DESCRIBED AS DRIFT IN K+ READING, WITH NO DELAY, NO BLOOD LOSS, AND SUCCESSFUL COMPLETION OF THE PROCEDURE. THE TEAM INDICATED THIS OCCURS ABOUT TWO OF EVERY 20 CASES. THE USERS MANUALLY CALIBRATE MID-CASE WHICH CORRECTED THIS ISSUE. THE USERS ARE AWARE OF THE DRIFTING ISSUE AND CHECK MANUAL BLOOD GASES. THEY DO NOT GIVE K+ BASED ON BPM READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185930 ↗MalfunctionJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE BLOOD PARAMETER MONITOR (BPM) VALUES WERE TRENDING FARTHER THAN EXPECTED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19455051 ↗MalfunctionJun 20, 2023Incorrect, 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) HEMATOCRIT (HCT) VALUES WERE INACCURATE. 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 17166565 ↗MalfunctionMar 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BLOOD PARAMETER MONITOR (BPM) FAILED TEMPERATURE ACCURACY TESTING WITH A READING OF 13.2 DEGREES CELSIUS (C), WHICH WAS BELOW THE MINIMUM SPECIFICATION OF 15 DEGREES C. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511963 ↗MalfunctionJun 22, 2022Incorrect, 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) READINGS WERE INACCURATE. 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 14777556 ↗MalfunctionMay 7, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE ARTERIAL BLOOD PARAMETER MONITOR (BPM) PROBE FAILED THE HIGH POTENTIAL (HI-POT) TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14315545 ↗MalfunctionMay 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) BLOOD GAS RESULTS WERE NOT ACCURATE AND WERE DRIFTING OFF BY LARGE QUANTITIES. THERE WAS NO DELAY. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14272605 ↗MalfunctionMar 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE VENOUS BLOOD PARAMETER MONITOR (BPM) PROBE FAILED MEASURED TEMPERATURE ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13655457 ↗MalfunctionJan 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE VENOUS BLOOD PARAMETER MONITOR (BPM) PROBE FAILED MEASURED TEMPERATURE ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13238031 ↗MalfunctionDec 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BLOOD PARAMETER MONITOR (BPM) ARTERIAL TEMPERATURE MEASURED VALUES WERE READING BELOW SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923762 ↗MalfunctionOct 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PER CLINICAL REVIEW: ON (B)(6) 2021, THE TEAM EXPERIENCED A PROBLEM WITH THE BLOOD PARAMETER MONITOR (BPM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. THEY REPORTED THAT THE UNIT STOPPED SENDING DATA DURING THE CASE. THE END USER PROCEEDED TO TURN OFF THE UNIT, REPLACED THE SENSORS, AND RESTARTED THE UNIT AND IT FUNCTIONED AS NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO BLOOD LOSS, AND NO CHANGE-OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12583643 ↗MalfunctionSep 27, 2021Incorrect, 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) WAS NOT SENDING DATA TO THE DATA COLLECTION SYSTEM. UPON REPLACING THE SENSORS AND REBOOTING THE SYSTEM, THE ARTERIAL MEASURED PARAMETERS WERE LARGER THAN EXPECTED, AND THE VENOUS MEASURED PARAMETERS WERE ALSO DIFFERENT THAN WHERE THEY WERE PREVIOUSLY. 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 12538012 ↗MalfunctionSep 23, 2021Thermal Decomposition of Device; Thermal Decomposition of Device
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BLOOD PARAMETER MONITOR HAD A HEAT DAMAGED CAPACITOR AT THE C107 POSITION ON THE AUXILIARY (AUX) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) CAUSING THE MONITOR TO FAIL POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12521849 ↗MalfunctionAug 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PER CLINICAL REVIEW: THE TEAM AT THE USER FACILITY HAD AN INCIDENT WITH THE BLOOD PARAMETER MONITOR (BPM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2021. THE TEAM SET UP AND CALIBRATED THE BPM WITHOUT ISSUE. AFTER THE FIRST IN-VIVO CALIBRATION ON CPB, THE PERFUSIONIST NOTICED THAT THE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) AND PARTIAL PRESSURE OF OXYGEN (PO2) VALUES WERE VERY OFF FROM THE BLOOD GASES, EXAMPLE OF PCO2 OF 37 MILLIMETERS OF MERCURY (MMHG) ON THE BPM AND THE BLOOD GAS ANALYZER WAS READING 47 MMHG. THE TEAM DID MORE BLOOD GAS VALUES DURING THE PROCEDURE, AND EXCHANGED THE BPM AFTER THE PROCEDURE. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274414 ↗
Other Terumo Cardiovascular Systems Corporation products
- Terumo Advanced Perfusion System 131 models · 1,869 reports · 11 recalls
- Cardiovascular Procedure Kit227 models · 92 reports · 2 recalls
- Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir6 models · 99 reports · 1 recall
- CDI Blood Parameter Monitoring System 5502 models · 75 reports
- CDI OneView Monitoring System3 models · 6 reports · 1 recall
- Sarns Cardioplegia Set3 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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