Terumo® Advanced Perfusion System 1 802111Recalls & reported problems
Terumo Cardiovascular Systems Corporation · The level detect module serves as the interface between the level sensor and the system. This module monitors level sensors mounted on a hardsheel blood reserviour and communicates any alerts or alarms to the system. · Class 2
All models of Terumo Advanced Perfusion System 1 (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Terumo Advanced Perfusion System level module monitors blood level during heart-lung bypass. The 32 reports mostly describe alarm and connection problems, such as false alarms, lost connections or failure to alarm, with staff switching to backup equipment and no patient harm mentioned. There were no deaths and no injuries, and no recalls name this device. Reports fell from 10 in the prior year to 2 in the most recent year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00886799000717), received between Mar 4, 2019 and Oct 16, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (17 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.
Reports received per month
Most reported problems
Device problems
- Device Alarm System17
- Output Problem6
- Device Sensing Problem2
- Disconnection2
- False Alarm2
- Connection Problem1
- Decoupling1
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient4
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR WAS NOT FUNCTIONAL PROPERLY AND 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 23311342 ↗MalfunctionAug 5, 2025Device Alarm System; Device Alarm System
AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE LEVEL ALARM STARTED ALARMING. AS MITIGATION, THE TEAM APPLIED GEL, AND THE ISSUE RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723607 ↗MalfunctionAug 5, 2025Device Alarm System; Device Alarm System
AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE LEVEL ALARM STARTED ALARMING. AS MITIGATION, THE TEAM APPLIED GEL, AND THE ISSUE RESOLVED. THEN THE AIR BUBBLE DETECTOR (ABD) ALARMED BUT QUICKLY WENT BACK TO GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723597 ↗MalfunctionAug 1, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL MODULE WAS NOT CONNECTING PROPERLY. 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 22687294 ↗MalfunctionMay 29, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE LEVEL MODULE WAS RANDOMLY ALARMING, BUT NO MESSAGE WAS DISPLAYED. 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 22107562 ↗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 SYSTEM 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 21963448 ↗MalfunctionApr 29, 2025Disconnection; Disconnection
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'LEVEL SENSOR NOT ATTACHED' MESSAGE. 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 21930324 ↗MalfunctionApr 29, 2025Disconnection; Disconnection
IT WAS REPORTED DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'LEVEL NOT ATTACHED' MESSAGE. 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 21930260 ↗MalfunctionFeb 19, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR 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 21417444 ↗MalfunctionFeb 6, 2025False Alarm; False Alarm
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR DISPLAYED A 'SENSOR NOT ATTACHED' MESSAGE. AS MITIGATION, THE PADS AND THE SENSORS WERE REPLACED 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 21326725 ↗MalfunctionSep 27, 2024Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ARTERIAL PUMP DID NOT PAUSE AS IT SHOULD HAVE BASED ON THE LOW-LEVEL SAFETY SETTINGS. 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 20323107 ↗MalfunctionMay 19, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) LEVEL BUTTON WAS ON, BUT THE ICON WOULD NOT ILLUMINATE OR WORK CONSISTENTLY. THERE WAS 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 16960328 ↗MalfunctionNov 14, 2022Device Alarm System; Output Problem; Device Alarm System; Output Problem
PER CLINICAL REVIEW: ON (B)(6) 2022, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) WHEREBY THEY GOT MULTIPLE ALERT TONES WITHOUT MESSAGES. THIS ISSUE OCCURRED DURING CARDIOPULMONARY BYPASS (CPB), WITH NO CHANGE OUT, NO BLOOD LOSS, NO DELAY, AND NO ADVERSE EVENT. THE CLINICIAN EVENTUALLY REALIZED THAT THE LEVEL ALERT SENSOR WAS NOT FULLY SEATED IN THE LEVEL PAD AND PROCEEDED TO RESEAT THE SENSOR. THE LOGS CONFIRMED THE ISSUE THAT WHEN THE LEVEL SENSOR GOES FROM COUPLED TO NOT ATTACHED AND BACK TO COUPLED FAST ENOUGH, ONLY THE AUDIO ALERT SOUNDS, BUT NO MESSAGE POPS UP ON THE CENTRAL CONTROL MONITOR (CCM). WHEN THIS OCCURS, THE PROPER MESSAGE IS POPULATED IN THE MESSAGES AREAS OF THE AUXILIARY (AUX) TAB, BUT USERS ARE OFTEN NOT AWARE OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15790472 ↗MalfunctionJul 27, 2022Device Alarm System; Output Problem; Device Alarm System; 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 'LEVEL SENSOR NOT ATTACHED' MESSAGE. 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 15113690 ↗MalfunctionFeb 17, 2022Output Problem; Output Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL DETECTION MODULE WAS NOT WORKING PROPERLY. 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 13550169 ↗MalfunctionFeb 16, 2022Output Problem; Output Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE LEVEL SENSOR DETECTOR MALFUNCTIONED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13546140 ↗MalfunctionFeb 16, 2022Output Problem; Output Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE LEVEL SENSOR DETECTOR MALFUNCTIONED. 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 13546125 ↗MalfunctionDec 9, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSORS WERE CONTINUOUSLY ALARMING. AS A MITIGATION, THE LEVEL SENSORS WERE TURNED 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 12971310 ↗MalfunctionSep 16, 2021Device Alarm System; Device Alarm System
PER CLINICAL REVIEW: ON (B)(6) 2021, THE TEAM REPORTED HAVING RANDOM LEVEL ALARMS (FALSE ALARMS) ON THE HEART LUNG MACHINE (HLM). THEY COMPLETED THE CASE SUCCESSFULLY, WITH NO DELAY, NO BLOOD LOSS AND NO CHANGE-OUT OF EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12484247 ↗MalfunctionSep 7, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSORS WERE CONTINUOUSLY ALARMING. AS A MITIGATION, THE LEVEL SENSORS WERE REPLACED AND THE ISSUE REMAINED. THE LEVEL MODULE WAS CHANGED OUT 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 12436708 ↗MalfunctionAug 24, 2021Output Problem; Output Problem
CORRECTED INFORMATION THAT THE REPORTED COMPLAINT OCCURRED PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12358109 ↗MalfunctionAug 10, 2021Device Alarm System; Decoupling; Device Alarm System; Decoupling
PER CLINICAL REVIEW: DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2021, THE PERFUSION TEAM HAD INTERMITTENT FALSE ALARMS ON THE LEVEL SENSING SYSTEM, WITHOUT A MESSAGE ON THE CENTRAL CONTROL MONITOR (CCM) AND WITHOUT A MESSAGE IN THE MESSAGING CENTER OF THE HEART LUNG MACHINE (HLM). THE TEAM SET UP AND ATTACHED THE LEVEL PADS PER THE MANUFACTURER'S RECOMMENDATIONS, USED GEL AND ATTACHED THE SENSORS TO ANOTHER MANUFACTURER'S ROUNDED RESERVOIR FOR THE PROCEDURE. DURING THE PROCEDURE, THE SYSTEM GAVE THE PERFUSIONIST SUBSEQUENT 'LEVEL NOT ATTACHED' MESSAGES. THE CLINICAL TEAM HAS SPOKEN TO THE CUSTOMER AND DISCUSSED OPTIONS ON THE RESERVOIR TO PLACE THE PADS, AND RE-INFORMED THE TEAM ON HOW TO USE THE GEL PAD. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12301334 ↗MalfunctionAug 5, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) WAS HAVING PHANTOM 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 12281715 ↗MalfunctionFeb 26, 2021Device Alarm System; Device Alarm System
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING FIELD INSTALLATION OF THE DEVICE, THE LEVEL SENSORS WERE ALARMING ON THE THIN SIDE OF TEST FIXTURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385166 ↗MalfunctionFeb 19, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) WAS PERIODICALLY ALARMING WITH NO MESSAGE DISPLAYED. 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 11350952 ↗
Other Console, Heart-Lung Machine, Cardiopulmonary Bypass devices
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- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page