Terumo® Advanced Perfusion System 1 195274Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00886799000496), received between Dec 12, 2018 and Dec 18, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (21 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 44 reports, in the reporter's own words as published by the FDA.

• 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 23839131 ↗
• MalfunctionAug 6, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED LEVEL SENSOR HAD A DISCONNECTED ALARM. AS MITIGATION, THE PERFUSIONIST TRIED ATTACHING THE LEVEL SENSORS TO SEVERAL DIFFERENT PADS, BUT THE ISSUE REMAINED. 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 22726551 ↗
• MalfunctionJul 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED LEVEL SENSOR WAS GIVING 'LEVEL SENSOR NOT ATTACHED' MESSAGES EVEN THOUGH IT WAS SECURELY ATTACHED. 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 22512086 ↗
• MalfunctionJun 27, 2025Connection Problem; Connection Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE RED LEVEL SENSOR KEPT GIVING A 'NOT ATTACHED' ALERT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346619 ↗
• MalfunctionJun 26, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED 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 22339721 ↗
• 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. 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 21963240 ↗
• MalfunctionApr 29, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED LEVEL ALARM DID NOT STOP THE ARTERIAL PUMP WHEN CLEAR CRYSTALLOID DROPPED BELOW THE LEVEL SENSOR BUT DID STOP THE ARTERIAL PUMP APPROPRIATELY WHEN THERE WAS BLOOD IN THE RESERVOIR. THE SENSOR 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 21930744 ↗
• MalfunctionApr 17, 2025Device Alarm System; Device Alarm System

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT WHEN BLOOD OR FLUID DROPPED BELOW THE RED ALARM LEVEL SENSOR, THE PUMP DID NOT SHUT OFF EVEN THOUGH THE SAFETY CONNECTION WAS SET UP TO SHUT OFF THE PUMP. 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 21855213 ↗
• 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 21599064 ↗
• MalfunctionOct 28, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'LEVEL NOT ATTACHED' MESSAGE. THE TEAM USED THE DEVICE FOR THE REMAINDER OF THE CASE WITHOUT THE LEVEL SENSOR. 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 20548295 ↗
• MalfunctionOct 17, 2024Device Alarm System; Device Alarm System

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE RED LEVEL SENSOR DID NOT PASS THE ALARM TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471104 ↗
• 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 18597755 ↗
• MalfunctionJan 26, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED 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 18587028 ↗
• MalfunctionJan 22, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE LEVEL SENSOR WAS FALSELY 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 18557123 ↗
• MalfunctionNov 2, 2023False Alarm; False Alarm

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED 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 18056012 ↗
• 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 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 17649581 ↗
• MalfunctionApr 17, 2023Output Problem; Output Problem

  UPON RECEIPT OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT THE RED LEVEL SENSOR DID NOT PASS RELEASE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752227 ↗
• MalfunctionMar 20, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ALARM LEVEL SENSOR WAS NOT WORKING. 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 16577097 ↗
• MalfunctionFeb 3, 2023Degraded; Degraded

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE RED LEVEL SENSOR TIP WAS FOUND TO BE PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293074 ↗
• MalfunctionFeb 3, 2023Degraded; Degraded

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE RED LEVEL SENSOR TIP WAS FOUND TO BE PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292950 ↗
• MalfunctionJan 17, 2023Material Deformation; Output Problem; Material Deformation; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED LEVEL SENSOR WAS NOT WORKING. 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 16188586 ↗
• MalfunctionOct 4, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE RED LEVEL SENSOR KEPT 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 15539183 ↗
• MalfunctionAug 31, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC LEVEL SENSOR WAS CONTINUOUSLY 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 15328909 ↗
• MalfunctionApr 21, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ALARM LEVEL SENSOR HAD INTERMITTENT ALARM FAILURES. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

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

  MAUDE report 14166051 ↗
• MalfunctionApr 14, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE RED LEVEL SENSOR GAVE ERRONEOUS ALARMS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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 14112355 ↗