CDI® Blood Parameter Monitoring System 550 550AVHCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00886799001783), received between Sep 10, 2019 and Nov 25, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 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, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJun 27, 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 CARBON DIOXIDE (CO2) VALUE WAS SHOWN AS 29 ON THE BLOOD PARAMETER MONITOR (BPM) BUT THE ACTUAL VALUE WAS DETERMINED TO BE 50. EVEN AFTER THE GAS CONDITION WAS CHANGED AND THE SENSOR WAS CHANGED, THE ISSUE REMAINED. 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 19623026 ↗
• MalfunctionMay 3, 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) DISPLAYED VALUES DID NOT MATCH THE BLOOD GAS VALUES SAMPLED 10-25 MINUTES AFTER RECALIBRATION. THE HEMATOCRIT VALUE WAS 5-8%, THE HEMOGLOBIN VALUE WAS AROUND 2, AND THE POTASSIUM WAS 4.3 ON THE BPM BUT THE GAS ANALYZER WAS READING 5.2. 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 19239952 ↗
• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: ON (B)(6) 2023, THE TEAM EXPERIENCED A PROBLEM WITH THEIR BLOOD PARAMETER MONITOR (BPM) WHILE ON CARDIOPULMONARY BYPASS (CPB), DESCRIBED AS 'ALL VALUES HAD SIGNIFICANT DEVIATION'. THE UNIT WAS CHANGED OUT, WITH NO BLOOD LOSS, NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNABLE TO BE CONFIRMED WHETHER OR NOT THE SYSTEM WAS CALIBRATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383116 ↗
• MalfunctionMay 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR BLOOD PARAMETER MONITOR (BPM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER OBSERVED A DEVIATION OF THE BASE EXCESS VALUE WHEN COMPARED TO THE VALUES OBTAINED FROM THE LAB. IT IS UNCLEAR IF THIS DEVIATION IS A POSITIVE OR NEGATIVE DEVIATION FROM THE LAB BLOOD GAS VALUES. THERE WAS NO DELAY TO THE PROCEDURE. THE UNIT WAS NOT CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS OR ADVERSE EVENTS REPORTED. THE USER CONFIRMED BASE EXCESS (BE) VALUES FROM AN ABL 90 FLEX BLOOD GAS ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003057 ↗
• MalfunctionMay 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR BLOOD PARAMETER MONITOR (BPM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER OBSERVED A DEVIATION OF THE BASE EXCESS VALUE WHEN COMPARED TO THE VALUES OBTAINED FROM THE LAB. IT IS UNCLEAR IF THIS DEVIATION IS A POSITIVE OR NEGATIVE DEVIATION FROM THE LAB BLOOD GAS VALUES. THERE WAS NO DELAY TO THE PROCEDURE. THE UNIT WAS NOT CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS OR ADVERSE EVENTS REPORTED. THE USER CONFIRMED BASE EXCESS (BE) VALUES FROM AN ABL 90 FLEX BLOOD GAS ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003033 ↗
• MalfunctionApr 4, 2023Thermal Decomposition of Device; Electrical Power Problem; Thermal Decomposition of Device; Electrical Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT BLEW A FUSE SO IT COULD NOT RUN ON ALTERNATING CURRENT (AC) POWER. 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 16678480 ↗
• MalfunctionNov 15, 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) POTASSIUM (K+) VALUE DEVIATED FROM THE TEST VALUE. 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. PER CLINICAL REVIEW: THE END USER REPORTED THAT THE BPM DISPLAYED A LARGE K+ VALUE DRIFT DURING CPB. THE END USER REPORTED THAT THE K+ VALUE DEVIATED FROM THE MEASURED LAB BLOOD GAS VALUE. THE SHUNT SENSOR IN QUESTION WAS MEASURING AN ARTERIAL K+ VALUE. THE K+ VALUE WAS EITHER DRIFTING FROM THE LAB MEASURED VALUE OR WAS READING 9.99 ON THE MONITOR SCREEN. THE END USER DECIDED TO SWITCH TO THE VENOUS SHUNT SENSOR AND THE K+ VALUE READ ACCURATELY. THIS OCCURRED DURING CPB, BUT DID NOT DELAY THE CASE, NO BLOOD LOSS RECORDED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797023 ↗
• MalfunctionMar 11, 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 13734001 ↗
• MalfunctionDec 15, 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 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 13012464 ↗
• MalfunctionJun 22, 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) VENOUS PROBE FAILED THE OVEN TEST WITH AN OUT OF SPECIFICATION TEMPERATURE READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044402 ↗
• MalfunctionJan 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE MANUFACTURER'S CLINICAL SPECIALIST ATTEMPTED TO GATHER INFORMATION ON THE COMPLAINT, THE PRIMING SOLUTION AND THE CADENCE OF THE PROCEDURE, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. THE TEAM HAD AN INCIDENT WITH THE BLOOD PARAMETER MONITOR (BPM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON 21-DEC-2020. THE TEAM SET UP AND CALIBRATED WITHOUT ISSUE FOR THE CASE. DURING THE PROCEDURE THE POTASSIUM DISPLAYED ONE MILLIMOLES PER LITER (MMOL/L). THE TEAM TRIED TO RE-INVIVO THE UNIT AND THE SENSOR WAS STILL READING THE SAME ONE MMOL/L VALUE. THE PATIENT'S POTASSIUM WAS IN THE NORMAL RANGE. THE TEAM INVIVO-ED NUMEROUS TIMES WITHOUT A CHANGE. THE UNIT WAS USED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11148466 ↗
• MalfunctionSep 10, 2019Incorrect, 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 VALUES FROM THE BLOOD PARAMETER MONITOR (BPM) SEEMED TO WANDER AND FLUCTUATE AND DID NOT SEEM TO BE CORRECT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW, DURING A CPB PROCEDURE SOMETIME BEFORE (B)(6) 2019, THE PERFUSION TEAM WAS CONCERNED THAT THEIR PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) VALUE WAS OUT OF RANGE AND INACCURATE. THE TEAM RUNS THE PRIME THROUGH THEIR SHUNT SENSOR PRIOR TO GOING ON BYPASS WITHOUT KNOWING WHAT THE POTENTIAL HYDROGEN (PH) OF THEIR PRIME SOLUTION IS. SECONDARILY, THE TEAM DOES NOT CALIBRATE THE SHUNT SENSORS WITH THE CALIBRATOR AND CALIBRATION GASES. THE DISCUSSION OCCURRED REGARDING THE DIFFERENCE BETWEEN PREVIOUS CALIBRATION AND FACTOR DEFAULTS, THE NEED FOR CALIBRATION, AND THE NEED TO ISOLATE THE SHUNT FROM THE PRIME SOLUTION IF THE PH OF THE SOLUTION WAS UNKNOWN. DURING THIS PROCEDURE THE TEAM DID NOT EXCHANGE THE UNIT FOR ANOTHER BPM. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984877 ↗