Terumo® Advanced Perfusion System 1 195215Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00886799000489), received between Oct 8, 2018 and Mar 26, 2026 — classified as 68 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE YELLOW LEVEL SENSOR WAS GIVING ALARMS. THE PERFUSIONIST ADJUSTED THE LEVEL SENSOR AND CHANGED OUT THE TEMPERATURE CABLE. 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 24701832 ↗
• MalfunctionDec 18, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR MODULE AND SCREEN FLASHED YELLOW AS IF A SENSOR WAS POORLY CONNECTED TO THE RESERVOIR. AS MITIGATION, THE TEAM REPLACED THE SENSORS AND THE ISSUE 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 23839022 ↗
• MalfunctionSep 10, 2025Device Alarm System; Device Alarm System

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE YELLOW LEVEL SENSOR WAS NOT ALARMING WHEN THE LEVEL WAS LOW. IT WAS ALARMING WHEN THE LEVEL SENSOR WAS DISCONNECTED BUT WHEN IT WAS ATTACHED TO A SURFACE WITH NO LIQUID ON THE OTHER SIDE, THE MODULE REMAINED GREEN AND DID NOT ALARM. LEVEL SENSOR GEL WAS APPLIED, AND THE LEVEL MODULE WAS CHANGED OUT, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018178 ↗
• MalfunctionAug 7, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE LEVEL SENSOR WAS NOT READING. 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 22740588 ↗
• MalfunctionJul 25, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE YELLOW LEVEL DETECTOR WAS FALSELY ALARMING EVEN WITH THE SUFFICIENT VOLUME PRESENT. AS MITIGATION, ONLY ONE LEVEL SENSOR WAS UTILIZED INSTEAD OF THE USUAL TWO. 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 22609989 ↗
• MalfunctionJul 16, 2025False Alarm; False Alarm

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522883 ↗
• MalfunctionJul 15, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS FALSELY ALARMING. 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 22511891 ↗
• MalfunctionJun 27, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL MODULE DISPLAYED A 'LEVEL: DISCONNECTED' MESSAGE, EVEN THOUGH THE SENSOR WAS CONNECTED. 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 22350097 ↗
• MalfunctionJun 26, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS REPEATEDLY GIVING 'NOT ATTACHED' ALARMS. 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 22339998 ↗
• MalfunctionMay 27, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE YELLOW LEVEL SENSOR WAS FALSE ALARMING. 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 22089040 ↗
• MalfunctionMay 5, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR WAS ALARMING THAT IT WAS NOT ATTACHED. 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 21963414 ↗
• MalfunctionMar 13, 2025Device Alarm System; Device Alarm System

  UPON RECEIPT OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'CHECK LEVEL' ALERT MESSAGE FOR BOTH LEVEL SENSORS ON THE THIN SIDE OF THE TEST FIXTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599040 ↗
• MalfunctionJan 14, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW ULTRASONIC LEVEL SENSOR WAS CONSTANTLY FALSE ALARMING EVEN THOUGH THERE WAS FLUID AT A LEVEL ABOVE THE SENSOR. THE SENSOR HOLDER WAS CHANGED OUT, BUT THE ISSUE REMAINED. THE SENSOR WAS CHANGED OUT AND NO FURTHER ISSUES OCCURRED. 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 21152928 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE END OF THE ULTRASONIC LEVEL SENSOR (UAS) WAS PULLED OFF AND WAS NO LONGER FUNCTIONAL. 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 20401813 ↗
• MalfunctionJul 9, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WOULD NOT DETECT THE RESERVOIR VOLUME AND KEPT ALARMING THAT THE FLUID WAS LOW. THE END USER ADDED THE LEVEL GEL AND A NEW LEVEL PAD, BUT THE ISSUE REMAINED. AT ONE POINT IT DID SEEM TO FUNCTION AS INTENDED BUT THEN REVERTED BACK TO ALARMING. 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 19706688 ↗
• MalfunctionJun 14, 2024Device Alarm System; Disconnection; Device Alarm System; Disconnection

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), A 'LEVEL SENSOR DISCONNECTED' ALARM OCCURRED. AS A RESULT, THE LEVEL SENSOR WAS REPLACED AND THE ISSUE 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 19538164 ↗
• MalfunctionMay 16, 2024Device Alarm System; Device Alarm System

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE LEVEL SENSOR DID NOT PASS RELEASE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335097 ↗
• MalfunctionJan 29, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR KEPT FALSELY ALARMING. 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 18597779 ↗
• MalfunctionJan 25, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS FALSELY ALARMING. 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 18579511 ↗
• MalfunctionJan 4, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL MODULE WAS BEEPING INTERMITTENTLY. 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 18448906 ↗
• MalfunctionNov 8, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS ALARMING SPORADICALLY. 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 18095333 ↗
• MalfunctionOct 25, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS ALARMING AND DISPLAYING A 'SENSOR DISCONNECTED' MESSAGE ON THE CENTRAL CONTROL MONITOR (CCM). 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 18007384 ↗
• MalfunctionAug 30, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL DETECTOR WAS UNABLE TO BE TURNED ON VIA THE CENTRAL CONTROL MONITOR (CCM). 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 17649565 ↗
• MalfunctionAug 21, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE YELLOW LEVEL SENSOR WAS UNEXPECTEDLY BEEPING. 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 17585613 ↗
• MalfunctionJun 19, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'DISCONNECTED' MESSAGE AS THE YELLOW LEVEL SENSOR FAILED. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158547 ↗