Terumo® Advanced Perfusion System 1 6382Recalls & reported problems
Terumo Cardiovascular Systems Corporation · The flow sensor is a non-invasive ultrasonic transducer used to measure fluid flow. Includes ultrasonic coupling gel. · 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 1 console runs cardiopulmonary bypass during heart surgery, and its flow sensor is an ultrasonic probe that measures fluid flow. The 63 reports mostly describe the sensor giving wrong or missing readings, alarms, and flow readings that drop out or register backflow when flow is moving forward; in the detailed cases, staff swapped in another sensor and surgery finished, sometimes with a delay. There are no deaths and no injuries, and no recalls name this device.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00886799000083), received between Jun 13, 2018 and Jan 6, 2026 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 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
- Incorrect, Inadequate or Imprecise Result or Readings19
- Device Alarm System13
- Output Problem11
- Unable to Obtain Readings9
- Break2
- Infusion or Flow Problem2
- Material Deformation2
- Calibration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient13
- No Patient Involvement4
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS DISPLAYING DATA 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 23983556 ↗MalfunctionDec 16, 2025No Device Output; No Device Output
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT READING. 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 23818473 ↗MalfunctionNov 3, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE FLOW SENSOR PROBE WAS MALFUNCTIONING AS IT WAS REGISTERING BACKFLOW WHEN THE FLOW OF THE FLUID WAS IN THE CORRECT DIRECTION. AS MITIGATION, THE PROBE WAS TAKEN OFF, PUT BACK ON AND TOOK A FEW MINUTES FOR THE SENSOR TO RESTART. THE SENSOR WAS REPLACED WITH ANOTHER SENSOR. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23458831 ↗MalfunctionSep 12, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW PROBE DID NOT INITIATE/READ ON FIRST START UP BUT WOULD WORK AGAIN IF COMPLETELY SHUT DOWN/RESTART OF THE SYSTEM. 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 23041380 ↗MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem
IT WAS REPORTED THAT THE FLOW PROBE WOULD NOT ZERO OUT. 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 22829911 ↗MalfunctionAug 6, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE FLOW PROBE WAS NOT READING. 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 22728110 ↗MalfunctionJul 25, 2025Output Problem; Output Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE FLOW SENSOR INDICATED A HIGHER FLOW RATE THAN WHAT WAS DISPLAYED ON THE ROLLER 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 22610053 ↗MalfunctionMay 31, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE FLOW PROBE STOPPED 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 22120737 ↗MalfunctionApr 1, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT READING. AS A RESULT, A SPARE FLOW SENSOR WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21746205 ↗MalfunctionNov 26, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE FLOW SENSOR HAD A BACKFLOW ALARM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A FIVE-MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20785221 ↗MalfunctionOct 17, 2024Connection Problem; Connection Problem
PER CLINICAL REVIEW: ON (B)(6) 2024, THE TEAM EXPERIENCED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) FLOW SENSOR DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'FLOW SENSOR NOT ATTACHED' MESSAGE. THE DEVICE WAS NOT CHANGED OUT AS THE PERFUSIONIST WAS ABLE TO MONITOR ARTERIAL PRESSURE, AORTIC PRESSURE, AORTIC LINE PRESSURE, REVOLUTIONS PER MINUTE (RPMS) AND URINE OUTPUT WHICH INDICATED ADEQUATE FLOW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO DELAY, NO BLOOD LOSS, AND NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471213 ↗MalfunctionSep 30, 2024Output Problem; Output Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT REGISTERING THE FLOW. 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 20332825 ↗MalfunctionJul 22, 2024Output Problem; Output Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE FLOW PROBE STOPPED 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 19794179 ↗MalfunctionJul 22, 2024Device Alarm System; Device Alarm System
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'BACK FLOW' MESSAGE WHEN THE CENTRIFUGAL DRIVE MOTOR WAS IDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19794134 ↗MalfunctionJun 4, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR GAVE A BACKFLOW 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19462260 ↗MalfunctionMar 6, 2024Unable to Obtain Readings; Unable to Obtain Readings
THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE FLOW PROBE WOULD NOT READ FLOW BUT ONCE THE SYSTEM REBOOTED, IT WORKED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846212 ↗MalfunctionAug 24, 2023Output Problem; Output Problem
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL FLOW SENSOR WOULD WORK INTERMITTENTLY AND DISPLAYED DASH MARKS AND THE LATCH WAS COMING UNDONE. 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 17618615 ↗MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW PROBE INCORRECTLY READ THE VALUES. AS MITIGATION, ALTERNATE DATA THAT WAS AVAILABLE FOR THE SAME PARAMETERS WERE RELIED UPON. 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 17379156 ↗MalfunctionJul 18, 2023Incorrect, 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 FLOW WAS SET TO 3 LITERS (L) PER MINUTE (MIN) BUT WAS READING 6L/MIN. AS MITIGATION THE FLOW SENSOR WAS UNPLUGGED AND PLUGGED BACK IN AND ONLY READ DASHES. 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 17342584 ↗MalfunctionJul 17, 2023Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE PUMP DISPLAYED A 'BACK FLOW' MESSAGE. THE PERFUSIONIST CHECKED THE FLOW SENSOR, THE FLOW MODULE, AND RESTARTED THE PUMP MULTIPLE TIMES UNTIL THE UNIT FUNCTIONED NORMALLY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 SECOND DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17337266 ↗MalfunctionJun 28, 2023Device Alarm System; Device Alarm System
PER CLINICAL REVIEW: ON 05JUN2023, THE TEAM EXPERIENCED A SITUATION WITH THEIR HEART LUNG MACHINE (HLM) DESCRIBED AS 'BACKFLOW ALARM WHEN THE CENTRIFUGAL PUMP WAS NOT RUNNING' DURING CARDIOPULMONARY BYPASS (CPB). THERE WAS NO CHANGE OUT, NO DELAY, AND NO BLOOD LOSS. THE CUSTOMER CLAMPED THE TUBING TO MITIGATE THE BACKFLOW ALARM. WHILE THIS WAS FILED AS A FALSE ALARM, THIS IS ACTUALLY THE INTENDED BEHAVIOR OF THE BACKFLOW ALARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17218795 ↗MalfunctionMay 5, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT READING. 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 16875928 ↗MalfunctionNov 15, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR PINS WERE BENT. 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 15797239 ↗MalfunctionAug 22, 2022Break; Break
THE MANUFACTURER'S SUBSIDIARY'S SERVICE TECHNICIAN REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, PART OF THE FLOW SENSOR COVER CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15272332 ↗MalfunctionJun 27, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR HAD INTERMITTENT BACK FLOW ALARMS. 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 14835795 ↗
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.
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