Terumo® Advanced Perfusion System 1 801188Recalls & reported problems

Summary

The FDA's MAUDE database contains 447 adverse event reports that list this exact device (DI 00886799000588), received between May 18, 2018 and Sep 29, 2026 — classified as 1 injury, 446 malfunctions.

The most frequently reported specific device problem is “Output Problem” (110 reports).

3 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. Jun 8, 2021Class IITerminated

   intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

   Z-2350-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Oct 17, 2018Class IITerminated

   An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.

   Z-1769-2019 · Root cause: Process control · Recall details · FDA record ↗

3. Sep 13, 2018Class IITerminated

   The service manual was not updated at the time of the release of software version 1.30.

   Z-0176-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 447 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936786 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765161 ↗
• MalfunctionAug 14, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253407 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS SET AT 70 AND THE PARAMETER ON THE MONITOR WAS READING 50. THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) CALIBRATED SUCCESSFULLY UPON BOOT UP BUT THEN PROMPTED FOR REPEATED 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 24703237 ↗
• MalfunctionMar 24, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SERVICE GAS SYSTEM' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675681 ↗
• MalfunctionMar 23, 2026Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) GAVE A SERVICE GAS SYSTEM ALARM. 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: Insufficient Information

  MAUDE report 24669541 ↗
• MalfunctionMar 17, 2026Failure to Calibrate

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) WOULD NOT CALIBRATE UPON BOOT UP AND A CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'FAILED CALIBRATION AND KNOB ADJUST ONLY' MESSAGE. THE TEAM USED THE LOCAL CONTROL KNOBS AND A CHANGE IN THE SWEEP/FRACTION OF INSPIRED OXYGEN (FIO2) WAS DISPLAYED ON THE SCREEN BUT THE CONTROLS ON THE MACHINE WERE NOT USABLE. THE TEAM TOOK THE LINE OFF WHEN TESTING THE MANUAL CONTROLS AND COULD FEEL AIRFLOW, CONFIRMING FLOW THROUGH THE REGULATOR AND THE PHYSICAL FLOW METER VISIBLY MEASURED GAS FLOW. THE LINE WAS CONNECTED TO THE OXYGENATOR DURING CALIBRATIONS. RECALIBRATION WAS ATTEMPTED A FEW MORE TIMES, BUT THE ISSUE REMAINED. 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 24621171 ↗
• MalfunctionMar 9, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FLOW WAS DIFFERENT THAN THE POLE MOUNTED FLOW METER. AS MITIGATION, THE PERFUSIONIST INCREASED FLOW AS NEEDED. 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 24552279 ↗
• MalfunctionFeb 19, 2026Failure to Calibrate

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE OXYGEN (O2) ANALYZER WOULD NOT CALIBRATE, AND A 'LOW AIR PRESSURE' ALARM DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388879 ↗
• MalfunctionFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) READINGS WERE FLUCTUATING ON THE CENTRAL CONTROL MONITOR (CCM) DISPLAY. 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 24261054 ↗
• MalfunctionJan 30, 2026Calibration Problem

  UPON RECEIPT OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FAILED CALIBRATION, WITH AN 'OXYGEN (O2) SENSOR OUT OF RANGE' ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223019 ↗
• MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FRACTION OF INSPIRED OXYGEN (FIO2) WAS FLUCTUATING AS THE SET POINT WAS 80 AND THE VALUE DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM) WAS 96. 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 24089536 ↗
• MalfunctionDec 16, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE OCCURRED DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. THE TEAM ATTEMPTED MULTIPLE CALIBRATIONS, BUT THE ISSUE REMAINED. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818766 ↗
• MalfunctionNov 24, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'LOW AIR SUPPLY PRESSURE' MESSAGE ABOUT 3/4 OF THE WAY THROUGH THE CASE. THE TEAM MUTED THE EVENT, AND IT SILENCED AND DID NOT REOCCUR. T HE 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 23638480 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  IT WAS REPORTED THAT DURING SETUP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FRACTION OF INSPIRED OXYGEN (FIO2) ANALYZER CALIBRATION FAILED. THE GAS CALIBRATION NEEDED TO BE REPEATED MULTIPLE TIMES, AND THE FIO2 READINGS WERE NOT ACCURATE WHEN COMPARING THEM AGAINST THE ARTERIAL BLOOD GAS (ABG) VALUES. THE FIO2 READINGS ON THE PUMP WERE FLUCTUATING WITHOUT REASON WHILE THE ACTUAL VENT SETTINGS REMAINED UNCHANGED. 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 23617777 ↗
• 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 ELECTRONIC PATIENT GAS SYSTEM (EPGS) FRACTION OF INSPIRED OXYGEN (FIO2) WAS FLUCTUATING. 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 23397437 ↗
• MalfunctionSep 19, 2025Calibration Problem; Output Problem; Calibration Problem; Output Problem

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, AIR AND OXYGEN (O2) WERE INTRODUCED INTO THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) IN AN ATTEMPT TO CALIBRATE THE O2 ANALYZER AND A 'SERVICE GAS SYSTEM' MESSAGE DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096672 ↗
• MalfunctionSep 15, 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 ELECTRONIC PATIENT GAS SYSTEM (EPGS) VALUES WERE FLUCTUATING AND NEEDED A RECALIBRATION. AS MITIGATION, THE EPGS WAS RECALIBRATED, AND THE ISSUE WAS RESOLVED. 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 23057316 ↗
• MalfunctionSep 9, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ARTERIAL BLOOD WAS DARK, MATCHING THE COLOR OF THE VENOUS BLOOD. THE ARTERIAL PARTIAL PRESSURE OF OXYGEN (PO2) ON THE ARTERIAL BLOOD GAS (ABG) READ 599. THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS TURNED FROM 80% TO 100% AND THE COLOR CHANGED TO BRIGHT RED WITHIN 30 SECONDS. THE TEAM RECONNECTED THE HIGH-PRESSURE ARTERIAL LINE AND THE PRESSURE WAS WITHIN LIMITS. 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 23006390 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE GAS FLOW ON THE CENTRAL CONTROL MONITOR (CCM) AND THE EXTERNAL FLOWMETER DID NOT MATCH. THERE WERE NO REPORTED 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 22900461 ↗
• MalfunctionAug 21, 2025Failure to Calibrate; Failure to Calibrate

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) STARTED BUT FAILED CALIBRATION AFTER A FEW SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861771 ↗
• MalfunctionAug 14, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) HAD LOW OXYGEN (O2) OUTPUT. THE EPGS WAS USED AS IS FOR THE REMAINDER OF THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805253 ↗
• MalfunctionAug 1, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OXYGEN (O2) SENSOR FAILED. 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 22692639 ↗
• MalfunctionJul 17, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED AN 'O2 SENSOR FAILURE' MESSAGE FROM THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535079 ↗
• MalfunctionJul 8, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SERVICE GAS SYSTEM' MESSAGE. AS A RESULT, AN ALTERNATIVE 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 22445832 ↗