CDI™ Blood Parameter Monitoring System 500 500AHCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886799001622), received between Oct 4, 2018 and Dec 18, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 reports).

4 other recalls cover devices cleared under the same FDA submission (K133658); 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 25 most recent of 27 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS CONCLUDED THAT THE REPORTED ISSUE OCCURRED DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. PER CLINICAL REVIEW: THE MANUFACTURER'S CLINICAL SPECIALIST SPOKE WITH THE PERFUSIONIST REGARDING THE INCIDENT THE TEAM HAD WITH THE BLOOD PARAMETER MONITOR (BPM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2021. THE BPM PASSED THE COLOR CHIP TEST WITHOUT ISSUE. THE TEAM INITIATED CPB AND THE BPM VENOUS SATURATION WAS READING 100% BEFORE AND AFTER THE VENOUS IN-VIVO CALIBRATION. THE PERFUSIONIST DID NOT EXCHANGE THE UNIT OUT AND CONTINUED THE PROCEDURE WITHOUT THE CORRECT READING. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697597 ↗
• MalfunctionFeb 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE MANUFACTURER CLINICAL SPECIALIST SPOKE WITH THE PERFUSIONIST REGARDING AN INCIDENT THE TEAM HAD WITH THE BLOOD PARAMETER MONITOR (BPM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE IT WAS NOTED THAT THE PATIENT'S TEMPERATURE WAS APPROXIMATELY 28 DEGREES CELSIUS, THE BPM WAS READING SEVEN DEGREES BELOW WHAT THE PATIENT'S TEMPERATURE WAS. THE PERFUSIONIST TEAM DOES UNDERSTAND PER PRACTICE AND UNDERSTANDING FROM USE OF THE BPM FOR YEARS, THAT THE THERMISTOR IN THE DISPOSABLE AND THE CORRESPONDING READING DOES NOT CORRELATE TO PATIENT TEMPERATURE. THE CONCERN WAS THE POTENTIAL HYDROGEN (PH) AND THE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) POST IN-VIVO WAS VERY INACCURATE. THE CONCERN ABOUT THE TEMPERATURE BEING DRASTICALLY DIFFERENT THAN WHAT THEY WOULD NORMALLY SEE ON THE BPM, COOLING TO THE SAME TEMPERATURE ON VARIOUS OTHER SURGERIES. THE TEAM OPTED TO EXCHANGE THE UNIT AND ALL VALUES, INCLUDING THE TEMPERATURE WERE TRENDING AS EXPECTED. THERE WAS NO BLOOD LOSS OR HARM ASSOCIATED WITH THE EVENT. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294090 ↗
• MalfunctionAug 28, 2020Smoking; Sparking; Smoking; Sparking

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THERE WAS SMOKE AND SPARK COMING FROM THE POWER CORD OF THE BLOOD PARAMETER MONITOR (BPM) PLUGGED INTO THE HEART LUNG MACHINE (HLM). THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465267 ↗
• MalfunctionMay 29, 2020Incorrect, 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) WAS GIVING AN INACCURATE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) READING. AS A RESULT, BLOOD GASES WERE MANUALLY CHECKED ABOUT EVERY 15 MINUTES UNTIL THE CASE WAS DONE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE PERFUSIONIST WAS CONTACTED REGARDING THE INCIDENT THE TEAM HAD WITH THE BPM DURING A CPB PROCEDURE ON (B)(6) 2020. THE TEAM STATED THAT THE PCO2 WAS DRIFTING FROM THE BLOOD GAS ANALYZER APPROXIMATELY 20 MMHG DURING THE ENTIRETY OF THE PROCEDURE. SHE STATED THAT THEY RECALIBRATED THE PCO2 SEVERAL TIMES, AND IT WOULD DRIFT AWAY FROM THE ACTUAL TRENDING WITHIN 30 MINUTES REPEATEDLY, AND THAT IT WAS SIGNIFICANT ENOUGH THAT IT INFLUENCED THEM TO TAKE BLOOD GASES ABOUT EVERY 15 MINUTES. THE TEAM DID NOT GAS CALIBRATE THE SHUNT SENSOR PRIOR TO USING IT ON THE PROCEDURE. IT IS NOT THEIR PRACTICE TO GAS CALIBRATE, AND THE TEAM WAS INFORMED OF THE NEED FOR GAS CALIBRATION FOR THE ACCURACY OF THE GAS VALUES. THERE WAS NO HARM OR BLOOD LOSS DUE TO THIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102986 ↗
• MalfunctionApr 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SERVICE TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE MANUFACTURER'S SUBSIDIARY'S SERVICE CENTER, THE BLOOD PARAMETER MONITOR (BPM) TEMPERATURE MEASUREMENTS WERE CONSTANTLY FLUCTUATING AND SLIGHTLY LOWER THAN THE ACTUAL TEMPERATURE OF THE FLUID. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9922392 ↗
• MalfunctionFeb 28, 2020Incorrect, 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 HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) 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. PER CLINICAL REVIEW: DURING CPB ON (B)(6) 2020, THE BLOOD PARAMETER MONITOR (BPM) WAS POWERED UP AND PASSED COLOR CHIP TEST WITHOUT AN ISSUE. DURING CPB, APPROXIMATELY FOUR HOURS INTO THE BYPASS RUN (POST IN-VIVO CALIBRATION) THE BPM STARTED TO GIVE INACCURATE NUMBERS ON THE HCT AND HGB, AND THE VENOUS SATURATION VALUE DID NOT APPEAR. THERE WAS NOTHING WRONG WITH THE PATIENT, OR THE PHYSICAL PROBE OR CUVETTE, FOR IT HAD WORKED PERFECTLY UP UNTIL THIS ISSUE OCCURRED. THE TEAM CYCLED POWER, AND THE SAME RESULT OF THE HGB AND HCT NUMBERS GOING UP AND DOWN AND THE VENOUS SATURATION LEVELS NOT READING. THERE WERE NO ISSUES WITH THE ARTERIAL GASES. THE TEAM OPTED TO EXCHANGE THE UNIT DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770028 ↗
• MalfunctionFeb 17, 2020Incorrect, 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 CARBON DIOXIDE (CO2) VALUE DID NOT MATCH WITH THE MANUAL LABORATORY VALUES, THERE WAS A SIGNIFICANT INCREASE AND DECREASE. AS A RESULT, THE SWEEP GASES WERE INCREASED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE PERFUSIONIST WAS CORRESPONDED WITH REGARDING THE INCIDENT ON (B)(6) 2020 WITH THEIR BLOOD PARAMETER MONITOR (BPM). THE TEAM STATED THAT THE FIRST IN-VIVO AFTER GOING ON CPB HAD NO PROBLEMS. THE SECOND IN-VIVO HAD NO PROBLEMS AND NO REAL DISCREPANCIES. AFTER THIRD IN-VIVO, ELEVATED PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) WAS OBSERVED ON THE BPM 45 MMHG. CLINICAL ADJUSTMENTS WERE MADE AND THE BPM CONTINUED TO BE IN THE LOWER 50'S MMHG. ANOTHER IN-VIVO CALIBRATION WAS DONE 30 MINUTES LATER AND ARTERIAL BLOOD GAS (ABG) WAS READING PCO2 IN THE LOWER 30'S WHILE THE BPM WAS READING IN THE MID 50'S MMHG. THE TEAM STATED THAT THE THEY DID NOT GAS CALIBRATE THEIR SHUNT SENSORS PRIOR TO CPB. THE TEAM WAS NOT AWARE OF THE SODIUM AND PH RESTRICTIONS ON THEIR PRIMING SOLUTIONS. THE CLI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717766 ↗
• MalfunctionJan 9, 2020Incorrect, 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 VENOUS OXYGEN SATURATION (SVO2) WAS ALWAYS READING 100%. THE VALUE WOULD ALSO NOT RECALIBRATE. 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 Consequences Or Impact To Patient

  MAUDE report 9571279 ↗
• MalfunctionOct 31, 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 MONITOR HAD AN ERRONEOUS TEMPERATURE READING. OTHER AVAILABLE TEMPERATURE READINGS WERE USED AS AN ALTERNATIVE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM SET UP AND CALIBRATED THE BLOOD PARAMETER MONITOR (BPM) AND SHUNT SENSOR WITHOUT ISSUE FOR PROCEDURES ON (B)(6) 2019, AND (B)(6). SHORTLY AFTER COMMENCING CPB THE SHUNT SENSOR TEMPERATURE WENT FROM 36.5 TO 45 DEGREES CELSIUS (C). THE TEAM CONFIRMED THAT THEIR PATIENT'S TEMPERATURE WAS APPROPRIATE AT AROUND 36. THE TEAM RESEATED THE SHUNT SENSOR IN THE BPM HEAD AND AGAIN THE TEMPERATURE WAS READING 45 DEGREES C. IT WAS CONFIRMED THAT THE TEAM DID NOT NOTICE OR DETECT ANY OTHER PARAMETER INACCURACIES, BUT THE INTERVAL IN WHICH THEY TAKE ARTERIAL BLOOD GAS (ABG) WAS ABOUT EVERY 30 TO 45 MINUTES. THE TEAM STATED THAT IT WAS THE SAME MONITOR AND THE SAME LOT NUMBER FOR THE SHUNT SENSOR IN ALL THREE INSTANCES. THE TEAM DID SWITCH THE UNIT OUT AFTER THE PROCEDURE ON (B)(6). NONE OF INSTANCES WAS THERE A DELAY IN THE SURGICAL PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259673 ↗
• MalfunctionOct 31, 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 MONITOR HAD AN ERRONEOUS TEMPERATURE READING. OTHER AVAILABLE TEMPERATURE READINGS WERE USED AS AN ALTERNATIVE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM SET UP AND CALIBRATED THE BLOOD PARAMETER MONITOR (BPM) AND SHUNT SENSOR WITHOUT ISSUE FOR PROCEDURES ON (B)(6) 2019, AND (B)(6) 2019. SHORTLY AFTER COMMENCING CPB THE SHUNT SENSOR TEMPERATURE WENT FROM 36.5 TO 45 DEGREES CELSIUS (C). THE TEAM CONFIRMED THAT THEIR PATIENT'S TEMPERATURE WAS APPROPRIATE AT AROUND 36. THE TEAM RESEATED THE SHUNT SENSOR IN THE BPM HEAD AND AGAIN THE TEMPERATURE WAS READING 45 DEGREES C. IT WAS CONFIRMED THAT THE TEAM DID NOT NOTICE OR DETECT ANY OTHER PARAMETER INACCURACIES, BUT THE INTERVAL IN WHICH THEY TAKE ARTERIAL BLOOD GAS (ABG) WAS ABOUT EVERY 30 TO 45 MINUTES. THE TEAM STATED THAT IT WAS THE SAME MONITOR AND THE SAME LOT NUMBER FOR THE SHUNT SENSOR IN ALL THREE INSTANCES. THE TEAM DID SWITCH THE UNIT OUT AFTER THE PROCEDURE ON (B)(6) 2019. NONE OF INSTANCES WAS THERE A DELAY IN THE SURG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259667 ↗
• MalfunctionOct 24, 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 MONITOR HAD AN ERRONEOUS TEMPERATURE READING. OTHER AVAILABLE TEMPERATURE READINGS WERE USED AS AN ALTERNATIVE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM SET UP AND CALIBRATED THE BLOOD PARAMETER MONITOR (BPM) AND SHUNT SENSOR WITHOUT ISSUE FOR PROCEDURES ON (B)(6) 2019, (B)(6) AND (B)(6). SHORTLY AFTER COMMENCING CPB THE SHUNT SENSOR TEMPERATURE WENT FROM 36.5 TO 45 DEGREES CELSIUS. THE TEAM CONFIRMED THAT THEIR PATIENT'S TEMPERATURE WAS APPROPRIATE AT AROUND 36. THE TEAM RESEATED THE SHUNT SENSOR IN THE BPM HEAD AND AGAIN THE TEMPERATURE WAS READING 45 DEGREES C. IT WAS CONFIRMED THAT THE TEAM DID NOT NOTICE OR DETECT ANY OTHER PARAMETER INACCURACIES, BUT THE INTERVAL IN WHICH THEY TAKE ARTERIAL BLOOD GAS (ABG) WAS ABOUT EVERY 30 TO 45 MINUTES. THE TEAM STATED THAT IT WAS THE SAME MONITOR AND THE SAME LOT NUMBER FOR THE SHUNT SENSOR IN ALL THREE INSTANCES. THE TEAM DID SWITCH THE UNIT OUT AFTER THE PROCEDURE ON (B)(6). NONE OF INSTANCES WAS THERE A DELAY IN THE SURGICAL PR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234167 ↗
• MalfunctionSep 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE TEAM SET UP AND CLAIMED TO PLACE THE POTASSIUM CODE IN THE MONITOR FOR CALIBRATION OF THE POTASSIUM SENSOR FOR A PROCEDURE ON (B)(6) 2019. THERE ARE THREE OCCURRENCES NOTED IN THE COMPLAINT, FOR THE USER HAS STATED THAT THIS HAS HAPPENED ON A REGULAR BASIS. THE PERFUSIONIST STATED THAT THE TEAM ALSO CLAIMS TO DO AN IN-VIVO CALIBRATION WITH EACH OF THE ARTERIAL BLOOD GAS (ABG) DONE, AND IS A TIME INTERVAL OF APPROXIMATELY 30 MINUTES. WITHIN THE TIME FRAME THE POTASSIUM DRIFTS TO APPROXIMATELY 1.0 MMOL/L HIGHER THAN THE LISTED ABG VALUE. DURING THE PROCEDURE ON (B)(6) 2019, THE TEAM EXCHANGED THE UNIT AFTER THE SECOND IN-VIVO RECALIBRATION AND CONTINUED THE PROCEDURE WITHOUT ISSUE. THERE WAS NO BLOOD LOSS, DELAY OF CASE OR HARM DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9080967 ↗
• MalfunctionJun 24, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE ARTERIAL BLOOD PARAMETER MONITOR (BPM) FAILED THE HIGH POTENTIAL (HI-POT) TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8728169 ↗
• MalfunctionMar 14, 2019Smoking; Smoking

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER SAW AND SMELLED SMOKE FROM THE UNIT WHEN IT WAS TURNED ON. THE UNIT WAS TURNED OFF AND NOT USED THROUGHOUT THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422039 ↗
• MalfunctionJan 16, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FIRST ON-PUMP CARBON DIOXIDE (CO2) WAS READING 100 MMHG, WHICH DID NOT MATCH THE INDEPENDENT BLOOD GAS THAT WAS DRAWN. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE UNIT WAS CALIBRATED FOR A PROCEDURE BY THE PERFUSIONIST, WITHOUT ISSUE. THE PERFUSIONIST ON THAT PROCEDURE NOTED THAT THE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) PRIOR TO THE FIRST IN-VIVO CALIBRATION WAS READING 100 MMHG. HE TOOK AN ARTERIAL BLOOD GAS AND RE-CALIBRATED THE UNIT WITHOUT ISSUE, AND THE PCO2 ADJUSTED AND WAS WITHIN SPECIFICATIONS THE REMAINDER OF THE PROCEDURE. IT WAS REITERATED TO THE TEAM THAT THE GASES ARE NOT WITHIN ACCURACY SPECIFICATIONS UNTIL AFTER THE FIRST IN-VIVO CALIBRATION. THIS INCIDENT DID NOT DELAY THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254910 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133658. One submission often covers many models, so check the product and lot details in each record.

• Z-2750-2018 · Jun 26, 2018 · Terminated
  CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure o
• Z-2751-2018 · Jun 26, 2018 · Terminated
  Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provide
• Z-1250-2016 · Mar 14, 2016 · Terminated
  CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extrac
• Z-2742-2015 · Aug 7, 2015 · Terminated
  CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen sa