CDI Blood Parameter Monitoring System 550Recalls & reported problems across all models

We found 2 models of CDI Blood Parameter Monitoring System 550 by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2019 and Apr 7, 2026 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (69 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

Most reported CDI Blood Parameter Monitoring System 550 problems

CDI Blood Parameter Monitoring System 550 models

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

• CDI® Blood Parameter Monitoring System 550 550AHCT

  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
  59 reports
• CDI® Blood Parameter Monitoring System 550 550AVHCT

  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
  16 reports

Recent CDI Blood Parameter Monitoring System 550 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Incorrect, 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+) AND CARBON DIOXIDE (CO2) VALUES WERE INACCURATE. THE K+ VALUE DISPLAYED WAS 5.7 WHICH DID NOT MATCH THE BLOOD GAS ANALYZER VALUE OF 4.6. AS MITIGATION, THE TEAM USED THE BLOOD GAS ANALYZER FOR THE REMAINDER OF THE CASE. 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 24808810 ↗
• MalfunctionApr 7, 2026Incorrect, 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+) AND CARBON DIOXIDE (CO2) VALUES WERE INACCURATE. THE K+ VALUE DISPLAYED WAS 5.7 WHICH DID NOT MATCH THE BLOOD GAS ANALYZER VALUE OF 3.5. AS MITIGATION, THE TEAM USED THE BLOOD GAS ANALYZER FOR THE REMAINDER OF THE CASE. 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 24808684 ↗
• MalfunctionApr 7, 2026Incorrect, 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+) AND CARBON DIOXIDE (CO2) VALUES WERE INACCURATE. THE K+ VALUE DISPLAYED WAS 8.9 WHICH DID NOT MATCH THE BLOOD GAS ANALYZER VALUE OF 4.8. AS MITIGATION, THE TEAM USED THE BLOOD GAS ANALYZER FOR THE REMAINDER OF THE CASE. 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 24807771 ↗
• MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE TEMPERATURE DISPLAYED ON THE BLOOD PARAMETER MONITOR (BPM) WAS VERY DIFFERENT FROM THE READING ON THE CENTRAL CONTROL MONITOR (CCM). THE BPM TEMPERATURE READING SWITCHED FROM 17 DEGREES CELSIUS TO 31 DEGREES CELSIUS INSTANTLY. IT WAS STATED THAT THE UNSTABLE TEMPERATURE READINGS APPEARED TO AFFECT OTHER VALUES. THE TEAM CONTINUED TO USE THE DEVICE FOR THE REMAINDER OF THE CASE USING BLOOD GAS ANALYZER VALUES. 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 24456732 ↗
• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE BLOOD PARAMETER MONITOR (BPM) BEING USED IN CONJUNCTION WITH THE NEONATAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUDDENLY SHUT DOWN AND THEN AUTOMATICALLY RESTARTED. AFTER RECONNECTING THE UNIT TO THE HEMATOCRIT SATURATION (H/S) PROBE AND PERFORMING CALIBRATION, THE DATA ON THE DISPLAY WAS INACCURATE. THE CARBON DIOXIDE (CO2) WAS 37 BUT THE BPM DISPLAYED 46. THE PARTIAL PRESSURE OXYGEN (PO2) WAS 322 BUT THE BPM DISPLAYED 364. ANOTHER UNEXPECTED SHUTDOWN WAS FOLLOWED BY AN AUTOMATIC RESTART. THE PROCEDURE WAS ATTEMPTED USING THE PREVIOUS CALIBRATION VALUES; HOWEVER, THE GAS DATA SIGNIFICANTLY DEVIATED FROM THE ACTUAL MEASUREMENTS. 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 24421900 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE BLOOD PARAMETER MONITOR (BPM) BEING USED IN CONJUNCTION WITH THE NEONATAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUDDENLY SHUT DOWN AND THEN AUTOMATICALLY RESTARTED. AFTER RECONNECTING THE UNIT TO THE HEMATOCRIT SATURATION (H/S) PROBE AND PERFORMING CALIBRATION, THE DATA ON THE DISPLAY WAS INACCURATE. THE CARBON DIOXIDE (CO2) WAS 37 BUT THE BPM DISPLAYED 46. THE PARTIAL PRESSURE OXYGEN (PO2) WAS 322 BUT THE BPM DISPLAYED 364. ANOTHER UNEXPECTED SHUTDOWN WAS FOLLOWED BY AN AUTOMATIC RESTART. THE PROCEDURE WAS ATTEMPTED USING THE PREVIOUS CALIBRATION VALUES; HOWEVER, THE GAS DATA SIGNIFICANTLY DEVIATED FROM THE ACTUAL MEASUREMENTS. 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 24389930 ↗
• MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WAS 10-DEGREE CELSIUS DISCREPANCY BETWEEN THE TEMPERATURE AT THE CPB OUTLET AND THE BLOOD PARAMETER MONITOR (BPM) DISPLAY, DESPITE BOTH THE COLD/WARM WATER BATH AND THE CPB OUTLET SHOWING 34-DEGREES CELSIUS. THE READINGS ALIGNED LATER DURING THE CASE. 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 23652930 ↗
• MalfunctionNov 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) POTASSIUM (K+) READING WAS FALLING TO 1.3 EVEN THOUGH IT WAS JUST CALIBRATED AND THE K+ CODE ENTERED. AS MITIGATION, BLOOD GAS VALUES FROM THE BLOOD GAS ANALYZER WERE RELIED UPON DURING THE CASE. 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 23587438 ↗
• MalfunctionOct 27, 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 POTASSIUM (K+) AND CARBON DIOXIDE (CO2) DID NOT MATCH THE BLOOD GAS ANALYZER RESULTS AND WERE FLUCTUATING. 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 23397541 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BLOOD PARAMETER MONITOR (BPM) WAS NOT READING PROPERLY. 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 22117602 ↗
• MalfunctionMay 29, 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) TEMPERATURE VALUE WAS INACCURATE MULTIPLE TIMES. IT WAS USED FOR THE REMAINDER OF THE CASE. 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 22107200 ↗
• MalfunctionMay 29, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), SMOKE WAS SEEN COMING FROM THE BLOOD PARAMETER MONITOR (BPM) PRINTER. AS MITIGATION, THE TEAM UNPLUGGED THE UNIT AND DID NOT USE IT FOR THE REMAINDER OF THE CASE. 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 22105535 ↗
• MalfunctionMay 12, 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) DISPLAYED A LOW PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) VALUE. THE FIRST CALIBRATION THE PCO2 VALUE WAS 25 MILLIMETERS OF MERCURY (MMHG) WHILE THE BLOOD GAS WAS 44 MMHG. IT TOOK THE BPM APPROXIMATELY 15 MINUTES TO DISPLAY A VALUE THAT WAS CLOSE TO THE ACTUAL VALUE. AFTER A SECOND RECALIBRATION, THE DEVICE WAS USED FOR THE REMAINDER OF THE CASE WITH A VALUE THAT WAS APPROXIMATED. 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 22006735 ↗
• MalfunctionJan 14, 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) HAD INCORRECT AND INCONSISTENT CARBON DIOXIDE (CO2) READINGS. THERE WAS A 20-MINUTE DELAY TO ATTAIN CORRECT CO2 DATA. AS MITIGATION, A BLOOD GAS ANALYZER WAS USED THROUGHOUT THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154090 ↗
• MalfunctionOct 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), THERE WERE DIFFERENCES IN THE VALUES FROM THE BLOOD PARAMETER MONITOR (BPM) COMPARED TO THE BLOOD GAS ANALYZER (BGA). THE BGA WOULD SHOW THAT THE PATIENT HAD A SOMEWHAT LOWER PH THAN THE BPM INDICATED. BY THE THIRD SAMPLE, THE VALUES WOULD MATCH. AS MITIGATION, MORE BLOOD SAMPLES WERE PERFORMED TO OBTAIN MORE ACCURATE READINGS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422596 ↗

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 OneView Monitoring System3 models · 6 reports · 1 recall
• Sarns Cardioplegia Set3 models · 0 reports · 1 recall
• CDI Blood Parameter Monitoring System 5002 models · 39 reports