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

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00886799001790), received between Mar 14, 2019 and Apr 7, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (55 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 25 most recent of 59 reports, 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 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 ↗
• 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 ↗
• MalfunctionOct 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422359 ↗
• 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 20421561 ↗
• MalfunctionJul 16, 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) PARTIAL PRESSURE OF OXYGEN (PO2) WAS READING HIGH DESPITE CALIBRATION AND MULTIPLE BLOOD GAS RECALIBRATIONS. 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 19756525 ↗
• MalfunctionApr 24, 2024Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) SCREEN WAS BLANK UPON POWER UP. 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. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION WHERE IT WAS FOUND THAT THERE WERE INTERNAL COMPONENTS THAT HAD EVIDENCE OF HEAT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177614 ↗
• MalfunctionNov 21, 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) VENOUS OXYGEN SATURATION (SVO2) VALUE WAS DIFFERENT THAT THE BLOOD GAS ANALYSIS (BGA) VALUE BY 5-10%. 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 18181466 ↗
• MalfunctionAug 4, 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) POTASSIUM (K+) LEVELS WERE READING INCORRECTLY. THE BPM WAS RECALIBRATED MID CASE, IT WORKED FOR A SMALL PERIOD OF TIME, BEFORE THE READINGS WERE INCORRECT AGAIN. MANUAL BLOOD GAS ANALYSIS 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 17459862 ↗
• MalfunctionMay 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE BLOOD PARAMETER MONITOR (BPM) MEASURED VALUE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974113 ↗
• MalfunctionMar 21, 2023Electrical Shorting; Electrical Shorting

  THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BLOOD PARAMETER MONITOR (BPM) POWER SWITCH CONNECTOR SHORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584467 ↗
• MalfunctionNov 17, 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) MEASURED VALUES WERE VARYING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW: ON (B)(6) 2022, THE TEAM EXPERIENCED A PROBLEM WITH THE BPM DURING CPB WHEREBY THE TEMPERATURE MEASURE VALUE HAD VARIATION. THERE WAS NO BLOOD LOSS, NO DELAY, AND NO CHANGE OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813769 ↗
• MalfunctionNov 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 CARDIOPULMONARY BYPASS (CPB), THE BLOOD PARAMETER MONITOR (BPM) HAD LARGE DISCREPANCIES IN THE HEMOGLOBIN (HB) AND GASES FROM THE HEMATOCRIT (HCT) PROBE. AS MITIGATION, BLOOD GAS ANALYSIS WAS USED TO MONITOR THE PATIENT'S LEVELS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE USER REPORTED THE BPM DURING CPB HAD LARGE DISCREPANCIES IN HB AND VENOUS OXYGEN SATURATION (SVO2) VALUES WHEN COMPARED TO THEIR MEASURED VALUES FROM THE LAB BLOOD GAS ANALYZER. THEY REPORTED DURING USE THE HB VALUE WAS OFF BY 3G, AND AFTER IN VIVO CALIBRATION THE HB VALUE ON THE SCREEN DID NOT CHANGE. THE TEMPERATURE WAS READING HIGH WHEN THE PATIENT'S TEMPERATURE WAS 32 DEGREES. THE SATURATIONS THEN READ 50-60% WHEN THE VENOUS BLOOD GAS SAMPLES SHOWED MIXED VENOUS BLOOD WAS 75-80%. THESE INACCURACIES RESULTED IN, PER THE USER, TRIPLE THE NUMBER OF BLOOD GASES NEEDED TO VERIFY AGAINST THE BPM VALUES. ALTHOUGH, THERE WAS NO DELAY TO THE PROCEDURE, NO INJURY, BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE USER STATED THIS UNIT WAS PREVIOUSLY SENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734635 ↗
• MalfunctionAug 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS AN INCONSISTENCY IN THE TEMPERATURE READINGS FROM THE BLOOD PARAMETER MONITOR (BPM). THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202993 ↗
• MalfunctionAug 10, 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) HAD A MALFUNCTION. AS MITIGATION, BLOOD GAS ANALYSIS WAS USED TO MONITOR THE LEVELS OF THE PATIENT. 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 15199395 ↗
• MalfunctionJun 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 BLOOD PARAMETER MONITOR (BPM) FAILED MEASURED TEMPERATURE ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580613 ↗
• MalfunctionJun 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SETUP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WERE ISSUES WITH THE ACCURACY OF THE HEMATOCRIT (HCT) PARAMETER PRIOR TO IN VIVO CALIBRATION. AN IN VIVO CALIBRATION WAS DONE AND THE DEVICE WAS CONTINUED TO BE USED. 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 14577724 ↗