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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00886799001646), received between Aug 27, 2018 and Mar 9, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 1, 2021Degraded; Degraded

  THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING LABORATORY ANALYSIS OF THE DEVICE, THE POWER CORD WAS FOUND TO BE DAMAGED WITH CONDUCTIVE WIRES EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098807 ↗
• MalfunctionJul 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE TEAM HAD AN INCIDENT REGARDING THEIR MONITOR DURING CARDIOPULMONARY BYPASS (CPB) ON (B)(6) 2020. ACCORDING TO THE SALES REPRESENTATIVE THE TEAM DID NOT GAS CALIBRATE, BUT ACCORDING TO THE END USER ON THE CASE, THE MONITOR WAS SET UP ROUTINELY FOR THE PROCEDURE. POST THE FIRST IN-VIVO CALIBRATION, THE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) VALUES WERE 30 TO 40 MILLIMETER PER MERCURY (MMHG) ABOVE WHAT THE PATIENTS ARTERIAL BLOOD GAS (ABG) VALUES WERE FROM AN INDEPENDENT ANALYZER, AND CONTINUED THAT WAY DURING THE PROCEDURE. THEY DID A SECOND IN-VIVO AND RECEIVED SIMILAR RESULTS. THEY PROCEEDED WITHOUT A DELAY IN THE SURGICAL PROCEDURE. THE UNIT WAS NOT EXCHANGED OUT FOR IT WAS A RELATIVELY SHORT CASE AND ALL OTHER VALUES WERE WITHIN RANGE. THERE WAS NO HARM OR BLOOD LOSS DUE TO THIS OCCURRENCE.

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

  MAUDE report 10254851 ↗
• MalfunctionJul 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: MULTIPLE DILIGENCE ATTEMPTS WERE UNSUCCESSFUL IN OBTAINING ADDITIONAL CLINICAL INFORMATION. THE DETAILS AVAILABLE ARE THAT THE VALUES WERE OFF FROM WHAT WAS EXPECTED WHEN THE MONITOR WAS BEING USED DURING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10253428 ↗
• MalfunctionApr 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE UNIT WAS SET UP WITHOUT ISSUE FOR A PROCEDURE ON (B)(6) 2020. THE UNIT PASSED ITS COLOR CHIP. DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEMATOCRIT SATURATION MODULE (H/SAT) VALUES WERE INACCURATE POST IN-VIVO, THEREFORE THE CLINICIAN OPTED TO EXCHANGE THE UNIT. 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; No Consequences Or Impact To Patient

  MAUDE report 9939851 ↗
• MalfunctionMay 30, 2019Smoking; Smoking

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE DAMAGED LIQUID CRYSTAL DISPLAY (LCD) BACK LIGHT DRIVER IS CAUSING SMOKE AND A BLANK DISPLAY WHILE TURNING ON THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8655558 ↗
• MalfunctionSep 24, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT PROVIDED INACCURATE MEASUREMENTS FOR PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) AND PH LEVELS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: IT WAS STATED TO DATE THAT THE PERFUSIONIST HAS HAD FOUR DIFFERENT OCCURRENCES, WITH THE MOST RECENT OCCURRENCE BEING (B)(6) 2018 OF SIMILAR INACCURACIES WITH THE SAME BLOOD PARAMETER MONITORING (BPM) SYSTEM. THE TEAM CALIBRATES THEIR SHUNT SENSORS WITH GAS A AND GAS B, ALONG WITH PLACEMENT OF THE POTASSIUM (K+) CODE INTO THE MONITOR PRIOR TO EVERY PROCEDURE. THE TEAM CALIBRATES THE VALUES WITH THE FIRST IN-VIVO. THE PERFUSIONIST STATED THAT THE VARIANCES OF ALL THE VALUES (PH, PCO2) ARE OUT OF THE ACCURACY SPECIFICATIONS. DURING THIS PROCEDURE THE PCO2 AFTER APPROXIMATELY THREE HOURS ON BYPASS HAD PCO2 VALUES THAT WERE CLOSE TO 40 MILLIMETERS OF MERCURY (MMHG) OFF FROM THE ARTERIAL BLOOD GAS (ABG). THE PH HAD A LARGE DELTA FROM THE ABG MACHINE ALSO. THE PH ON THE ABG WAS 7.51, THE BPM WAS READING 7.26. THE PCO2 ON ABG WAS 25MMHG, THE BPM WAS RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903256 ↗
• MalfunctionAug 27, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE INITIAL CARBON DIOXIDE (CO2) AND PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) WERE OFF ON SEVERAL CASES. THE UNIT WAS RECALIBRATED. 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 7819988 ↗

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-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-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-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