Terumo® Advanced Perfusion System 1 802018Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00886799000687), received between Nov 29, 2018 and Mar 31, 2026 — classified as 1 death, 45 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (17 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. Jan 19, 2018Class IITerminated

   Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

   Z-1478-2018 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026No Device Output

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, CENTRIFUGAL PUMP DISPLAYED AN 'ART FLOW CHECK SENSOR' MESSAGE AND THE FLOW VALUE WAS SHOWN AS DASHES. AT THE TIME, THE FLOW MODULE LIGHT EMITTING DIODE (LED) WAS GREEN INDICATING NO APPARENT ISSUE WITH THE MODULE. 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 24749717 ↗
• MalfunctionDec 17, 2025Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE FLOW MODULE FAILED TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828832 ↗
• MalfunctionOct 22, 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 MODULE WAS READING DASHES UPON START UP BUT WOULD WORK ONCE THE SYSTEM WAS REBOOTED. 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 23361334 ↗
• MalfunctionJun 27, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW MODULE BACK FLOW KEPT ALARMING UPON POWER UP, EVEN THOUGH NO MOTORS WERE RUNNING AND THERE WAS NO MOVEMENT OF THE WATER IN THE TUBING. AS MITIGATION, THE FLOW SENSOR WAS UNPLUGGED, PLUGGED BACK INTO THE MODULE, 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 22350032 ↗
• MalfunctionMar 25, 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 MODULE 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 21687358 ↗
• MalfunctionOct 21, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, NO FLOW VALUE WAS BEING DISPLAYED BY THE FLOW MODULE. 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 20498717 ↗
• MalfunctionMar 21, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW READING WAS BEING DISPLAYED AS DASHES INSTEAD OF AN ACTUAL READING. 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 18955613 ↗
• MalfunctionNov 15, 2023Output Problem; Output Problem

  DURING FIELD INSTALLATION OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT THE FLOW MODULE FAILED TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142875 ↗
• MalfunctionOct 31, 2023Unable to Obtain Readings; Unable to Obtain Readings

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE FLOW RATE WOULD NOT DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040020 ↗
• MalfunctionSep 1, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW MODULE LOST CONNECTION DURING SET-UP OF THE PERFUSION SCREEN. 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 17669813 ↗
• MalfunctionAug 24, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW MODULE FAILED TO DETECT 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 17610987 ↗
• MalfunctionJun 7, 2023Power Problem; Power Problem

  STATUS LIGHT ON NEW FLOW MODULE DOES NOT TURN ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080285 ↗
• MalfunctionMar 27, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW OUTPUT WAS NOT READING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM HAD AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CPB. SPECIFICALLY, THE CENTRIFUGAL PUMP HAD ERRATIC FLOW READINGS, DISPLAYING ONE MOMENT AND THE NEXT MOMENT NOT READING. IT WAS UNCLEAR HOW LONG OF A PERIOD THERE WAS LOSS OF A FLOW READING. THE TEAM DID SUCCESSFULLY COMPLETE THE CASE MONITORING FLOW INTERMITTENTLY. THERE WAS NO DELAY. THE UNIT WAS NOT CHANGED OUT, NO BLOOD LOSS, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618909 ↗
• MalfunctionSep 19, 2022Output Problem; 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 'SERVICE MODULE ART FLOW' MESSAGE. 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 15451127 ↗
• MalfunctionMay 31, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW READING WAS NOT DISPLAYING ON THE CENTRAL CONTROL MONITOR (CCM) OR THE CENTRIFUGAL CONTROL UNIT (CCU). AS MITIGATION, THE FLOW MODULE WAS UNPLUGGED AND PLUGGED BACK IN. THE ISSUE WAS RESOLVED 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 14550484 ↗
• MalfunctionApr 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW READING WAS FLUCTUATING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112195 ↗
• MalfunctionApr 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, 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 READ '0.00' EVEN WITH 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 14086630 ↗
• MalfunctionMar 1, 2022Backflow; Backflow

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE UNIT HAD A BACK FLOW ALARM AND THERE WAS NO FORWARD FLOW. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SHORT DELAY OF ABOUT ONE TO TWO MINUTES WHILE TROUBLESHOOTING. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637475 ↗
• MalfunctionFeb 25, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROLLER UNIT (CCU) WAS GIVING A FALSE BACKFLOW ALARM. AS A MITIGATION, THE SENSOR WAS UNPLUGGED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ON (B)(6) 2022, THE TEAM AT THE USER FACILITY EXPERIENCED A PROBLEM WITH THE HEART LUNG MACHINE (HLM) WHEREBY A 'BACKFLOW ALARM KEPT GOING OFF FOR NO REASON'. THE MANUFACTURER'S CLINICAL SPECIALIST SPOKE AT LENGTH WITH THE PERFUSIONIST WHO EXPLAINED THAT THE PROBLEM HAPPENED PERIODICALLY, ALWAYS WITH THE SAME HLM, BUT NOT EVERY CASE. HE SAID THE BACKFLOW ALARM DOES NOT HAPPEN WHILE ON CPB, BUT DURING THE TIME OF NO FLOW JUST BEFORE OR JUST AFTER CPB. HE ALSO EXPLAINED THAT WHEN THIS BACKFLOW ALARM WAS OCCURRING, THE ONLY WAY TO MAKE IT STOP WAS TO UNPLUG THE SENSOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO BLOOD LOSS, AND NO CHANGE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598852 ↗
• MalfunctionOct 29, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT HAD NO FLOW READING WHILE PRIME WAS FLOWING AT FIVE LITERS PER MINUTE (LPM). AS MITIGATION THE PERFUSIONIST RESET POWER TO THE FLOW MODULE AND THE FLOW READINGS WERE RESTORED. 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 12720453 ↗
• MalfunctionOct 26, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT HAD CONSTANT BACK FLOW ALARMS. 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 12700854 ↗
• MalfunctionOct 19, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WERE CONSTANT BACKFLOW 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 12660112 ↗
• MalfunctionApr 8, 2021Unable 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 MODULE DID NOT DISPLAY A FLOW RATE READING AND WAS ONLY SHOWING ZEROS. THE FLOW MODULE WAS DISCONNECTED, RECONNECTED 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 11638306 ↗
• MalfunctionApr 7, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT READING FLOW. THE FLOW MODULE WAS UNPLUGGED, PLUGGED BACK IN 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 11631129 ↗
• MalfunctionApr 7, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR WAS NOT READING FLOW. THE FLOW MODULE WAS UNPLUGGED, PLUGGED BACK IN 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 11631077 ↗