Terumo® Advanced Perfusion System 1 5773Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00886799000038), received between Sep 10, 2018 and Sep 18, 2026 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (50 reports).

1 FDA recall record 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. Aug 25, 2020Class IITerminated

   Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

   Z-2959-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device Alarm System

  The Field Service Representative (FSR) reported that during preventive maintenance (PM) of the device, the ultrasonic air sensor (UAS) was not working. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819109 ↗
• MalfunctionMar 12, 2026Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ULTRASONIC AIR SENSOR (UAS) FALSELY ALARMED MULTIPLE TIMES. 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 24584122 ↗
• MalfunctionMar 3, 2026Device Alarm System

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY. THERE WAS AN ESTIMATED BLOOD LOSS FOR THE WHOLE CASE OF 2700 MILLILITERS (ML) THAT OCCURRED DURING THE CASE, PRIOR TO THE ISSUE WITH THE AIR BUBBLE DETECTOR (ABD). IT WAS STATED THAT THE BLOOD LOSS WAS NOT RELATED TO THE REPORTED ABD ISSUE. THE PATIENT HAD BLEEDING IN THE LUNG THAT NEEDED TO BE PATCHED AND WHILE DOING THAT, THE SURGEON ALSO NICKED THE AORTA AND CAUSED BLEEDING FROM THAT. THIS OCCURRED OFF BYPASS AND THE ABD ISSUES OCCURRED AFTER REINITIATION OF BYPASS. TESTING DID NOT FIND AIR AND THE PATIENT WOKE UP AND WAS TALKING AND FUNCTIONING AS NORMAL.

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

  MAUDE report 24501666 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), PART OF THE AIR BUBBLE DETECTOR (ABD) SENSOR BROKE OFF. 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 24456043 ↗
• MalfunctionJan 13, 2026Device Alarm System

  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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053510 ↗
• MalfunctionJan 7, 2026False Alarm

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) WAS GIVING FALSE 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 23989658 ↗
• MalfunctionNov 7, 2025False Alarm; False Alarm

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ULTRASONIC AIR SENSOR (UAS) WAS CONSTANTLY ALARMING AND WOULD NOT RESET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496980 ↗
• MalfunctionNov 5, 2025Device Alarm System; No Device Output; Device Alarm System; No Device Output

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE AIR BUBBLE DETECTOR (ABD) SENSOR WAS NOT RESPONDING. 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 23480413 ↗
• MalfunctionOct 24, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE AIR BUBBLE DETECTOR (ABD) WAS CONSTANTLY FALSE ALARMING, AND THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED AN 'AIR BUBBLE DETECTED' MESSAGE WHILE IT WAS 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 23378438 ↗
• MalfunctionSep 19, 2025Device Alarm System; Pumping Stopped; Device Alarm System; Pumping Stopped

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) GAVE FALSE ALARMS AND THE PUMP STOPPED. 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 23096056 ↗
• MalfunctionJul 31, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE AIR BUBBLE DETECTOR (ABD) WAS NOT WORKING. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22675957 ↗
• MalfunctionJul 24, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) WAS FALSE ALARMING. AS MITIGATION, THE SENSOR WAS REPLACED, 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 22591329 ↗
• MalfunctionJul 24, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) 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 22589108 ↗
• MalfunctionJul 17, 2025False Alarm; False Alarm

  DURING FIELD INSTALLATION OF THE DEVICE, THE USER REPORTED THAT THE AIR BUBBLE DETECTOR (ABD) KEPT ALARMING EVEN WHEN THERE WERE NO AIR BUBBLES PRESENT. THE MODULE AND THE CORD WERE REPLACED, BUT THE ISSUE REMAINED. THE ABD SENSOR WAS SWAPPED WITH AN ABD SENSOR FROM A DIFFERENT MACHINE AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535624 ↗
• MalfunctionJul 14, 2025False Alarm; Pumping Stopped; False Alarm; Pumping Stopped

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) FALSELY ALARMED, STOPPING THE ARTERIAL PUMP WHILE THERE WERE NO AIR BUBBLES IN THE ARTERIAL LINE. 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 22496281 ↗
• MalfunctionJul 3, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) WAS CONTINUOUSLY GIVING AN AIR ALARM EVEN WHEN THERE WAS NO AIR IN THE LINE. 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 22399282 ↗
• MalfunctionJun 26, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ULTRASONIC AIR SENSOR (UAS) WAS ALARMING WITH FLUID PRESENT IN THE LINE. IT 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 22342362 ↗
• MalfunctionJun 20, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ULTRASONIC AIR SENSOR (UAS) WAS ALARMING ERRONEOUSLY. AS MITIGATION, THE SENSOR WAS RESET AND 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 22298435 ↗
• MalfunctionJun 20, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ULTRASONIC AIR SENSOR (UAS) WAS ALARMING ERRONEOUSLY. AS MITIGATION, THE SENSOR WAS RESET AND 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 22298402 ↗
• MalfunctionMay 12, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) ALARM ERRONEOUSLY WENT OFF MULTIPLE TIMES. 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 22007373 ↗
• MalfunctionMay 8, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE AIR BUBBLE DETECTOR (ABD) WAS ALARMING ERRONEOUSLY. 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 21988695 ↗
• MalfunctionMay 5, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) WAS FALSE 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 21963805 ↗
• MalfunctionApr 29, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE AIR SENSOR WAS CONSTANTLY FALSE ALARMING. THE SENSOR PERFORMED PROPERLY DURING PRIMING BUT AS SOON AS CLEAR FLUID AND BLOOD WERE IN THE RESERVOIR, IT WOULD NOT STOP 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 21930777 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE BLACK LATCH ON THE AIR BUBBLE DETECTOR (ABD) WAS BROKEN. 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 21930141 ↗
• MalfunctionApr 4, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ULTRASONIC AIR SENSOR (UAS) STARTED ALARMING ONCE BLOOD REACHED THE AIR BUBBLE DETECTOR (ABD). AS MITIGATION, THE UAS WAS TURNED OFF 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 21775888 ↗