Terumo® Advanced Perfusion System 1 802114Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00886799000748), received between Jul 1, 2019 and Dec 10, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Output Problem” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE READING DID NOT DISPLAY ON 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 20892160 ↗
• MalfunctionOct 10, 2024Incorrect, 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 TEMPERATURE MODULE WAS NOT READING THE TEMPERATURE ACCURATELY. 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 20418015 ↗
• MalfunctionAug 8, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING LABORATORY EVALUATION TESTING OF THE DEVICE, THE RED PORT ON THE TEMPERATURE MODULE WAS NOT READING THE TEMPERATURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945943 ↗
• MalfunctionMay 13, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE DISPLAYED AN X AND A ? INSTEAD OF A 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 19302808 ↗
• MalfunctionMay 13, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE DISPLAYED AN X AND A ? INSTEAD OF A 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 19302165 ↗
• MalfunctionOct 25, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS REMOVED TO REPLACE A TEMPERATURE PROBE AND THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A QUESTION MARK ON THE SCREEN WHERE TEMPERATURE READINGS SHOULD HAVE BEEN PRESENT. AS MITIGATION, THE PERFUSIONIST DID NOT USE THE TEMPERATURE READING THROUGHOUT THE CASE AND USED THE PATIENT'S TEMPERATURE. 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 18008241 ↗
• MalfunctionMay 17, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE TEMPERATURE MODULE DID NOT WORK PROPERLY, ONLY DISPLAYING DASHES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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 16949309 ↗
• MalfunctionApr 6, 2023Device Alarm System; Incorrect, Inadequate or Imprecise Result or Readings; Device Alarm System; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS ALARMING AND DISPLAYING 999 DEGREES CELSIUS (C) 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 16690611 ↗
• MalfunctionMar 24, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE VENOUS TEMPERATURE PROBE STOPPED WORKING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM REPORTED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CPB. SPECIFICALLY, THE VENOUS TEMPERATURE PROBE STOPPED WORKING DURING A CASE. THE PROBE WAS SWITCHED TO BE PLUGGED INTO THE ARTERIAL PORT ON THE MODULE, AND READINGS WERE ABLE TO BE TAKEN. THE CASE WAS ABLE TO CONTINUE AND BE COMPLETED USING THE ARTERIAL READINGS FROM THE BLOOD PARAMETER MONITOR (BPM) AND VENOUS READINGS FROM THE ARTERIAL PORT OF THE MODULE. IT APPEARED TO JUST BE THE VENOUS PORT ON THE TEMPERATURE MODULE THAT STOPPED FUNCTIONING. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 16612185 ↗
• MalfunctionMar 9, 2023Device Alarm System; Device Alarm System

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE OCCURRED DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. PER CLINICAL REVIEW: ON (B)(6) 2023, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) DURING SET-UP FOR A CASE, WHEREBY ALL THE TEMPERATURES (CARDIOPLEGIA, ARTERIAL, VENOUS) STARTED TO ALARM FOR NO APPARENT REASON. THE MANUFACTURER'S CLINICAL REVIEW SPECIALIST COMMUNICATED WITH THE CLINICIAN, AND HE CONFIRMED THAT THE INCIDENT WAS DISCOVERED DURING SET-UP (NOT DURING CARDIOPULMONARY BYPASS) AND THAT THE ENTIRE HLM WAS CHANGED OUT BEFORE THE PATIENT WAS BROUGHT INTO THE ROOM, WITH NO DELAY OR BLOOD LOSS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511977 ↗
• MalfunctionNov 4, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS FLASHING YELLOW AND THEN TURNED RED. 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 15729412 ↗
• MalfunctionNov 3, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS FLASHING YELLOW AND THEN TURNED RED. 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 15719265 ↗
• MalfunctionOct 3, 2022Connection Problem; Output Problem; Connection Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS NOT OPERATING CORRECTLY AS IT COULD NOT BE ASSIGNED. 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 15528806 ↗
• MalfunctionMar 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE PERFUSIONIST STATED THAT THE ARTERIAL TEMPERATURE PROBE WAS READING LOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953436 ↗
• MalfunctionSep 22, 2021Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE HAPPENED DURING CARDIOPULMONARY BYPASS (CPB). THERE WAS NO DELAY. PER CLINICAL REVIEW: ON (B)(6) 2021, THE PERFUSIONIST EXPERIENCED A PROBLEM WITH THE CARDIOPLEGIA TEMPERATURE NO LONGER FUNCTIONING WHILE ON CPB. THE MANUFACTURER'S CLINICAL SPECIALIST SPOKE WITH THE PERFUSIONIST IMMEDIATELY AFTER THE CASE TO TROUBLESHOOT THE PROBLEM AND IT WAS DETERMINED THAT ONE OF THE INPUT PLUGS ON THE MODULE HAD FAILED, BUT THE MODULE ITSELF WAS NOT SHOWING AN INDICATION OF THE FAILURE. IT WAS ALSO REALIZED THAT THE TEAM HAD A SPARE TEMPERATURE MODULE ALREADY PLUGGED INTO THE NETWORK INTERFACE CARD (NIC) PANEL. THE MANUFACTURER'S CLINICAL SPECIALIST WALKED THE PERFUSIONIST THROUGH ASSIGNING THE SPARE MODULE IN THEIR HEART LUNG MACHINE (HLM) CONFIGURATION SO THAT THE CARDIOPLEGIA TEMPERATURE CABLE COULD BE PLUGGED INTO IT FOR FUTURE USE. IT WAS CONFIRMED THAT THE CARDIOPLEGIA TEMPERATURE WAS FUNCTIONAL WITH THE REPLACEMENT MODULE AND THE PERFUSIONIST SET THE DEFECTIVE MODULE ASIDE TO BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO DELAY, NO CHANGE OUT, AND NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513352 ↗
• MalfunctionMay 5, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE TEMPERATURE CABLES WERE NOT WORKING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, 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 11777579 ↗
• MalfunctionDec 1, 2020Output Problem; Output Problem

  PER CLINICAL REVIEW: ON (B)(6) 2020 DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE AT THE CLINICAL TEAM HAD ISSUES WITH TEMPERATURE SENSING SYSTEM. NO OTHER INFORMATION WAS GIVEN AT THIS POINT. PER INFORMATION AVAILABLE, THE USER STATED THAT TEMPERATURE SENSING SYSTEM DURING A PROCEDURE WAS NOT DISPLAYING THE ARTERIAL AND VENOUS TEMPERATURE ON THE CENTRAL CONTROL MONITOR (CCM). PER THE LOG DATA, THE ARTERIAL AND VENOUS TEMPERATURES WERE READING FROM 6:02AM TO 13:06, AND THE SENSORS WERE DISCONNECTED AT 14:16 AND 14:17. THE TEAM HAD CHANGED THE TEMPERATURE ALARM RANGES DURING THE PROCEDURE. IT IS UNKNOWN WHAT THE CONCERN OR ISSUE WAS, AND HOW IT WAS MITIGATED. IT IS UNKNOWN ABOUT A DELAY OR HARM. THERE IS ROUTINELY NO BLOOD LOSS RELATED TO THIS ISSUE. THERE IS TYPICALLY NO DELAY OR HARM DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10924848 ↗
• MalfunctionOct 13, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, ONE CHANNEL OF THE TEMPERATURE MODULE WAS NOT WORKING. AS A MITIGATION, ONLY ONE CHANNEL WAS USED. 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; No Consequences Or Impact To Patient

  MAUDE report 10673056 ↗
• MalfunctionNov 19, 2019Connection Problem; Connection Problem

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE TEMPERATURE MODULE DID NOT WORK AND WOULD NOT CONNECT TO THE HEART LUNG MACHINE (HLM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9343808 ↗
• MalfunctionOct 24, 2019False Alarm; False Alarm

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CUSTOMER COULD NOT SILENCE THE OVER-TEMPERATURE ALARM. 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) 2019, THE TEAM HAD THEIR SYSTEM SET UP TO MEASURE THE RECTAL TEMPERATURE AND THE BLADDER TEMPERATURE OFF OF ONE MODULE (TWO TEMPERATURE PORTS ON ONE MODULE). THE TEMPERATURE CABLES HOOKED UP TO THE MODULE ARE THIRD PARTY DEVICES. DURING THIS PARTICULAR PROCEDURE, THERE WAS A TEMPERATURE PROBE PLACED IN THE BLADDER TEMPERATURE PORT, AND IT WAS READING APPROPRIATELY. THERE WAS NO TEMPERATURE PROBE IN THE RECTAL TEMPERATURE PORT, YET THE ALARM FOR OVER TEMPERATURE AT 42.5 DEGREES CELSIUS (C) WAS ALARMING (OCCURRED TWICE). THE TEAM TROUBLESHOT THE PROBE BY PLACING THE BLADDER TEMPERATURE PROBE IN THE PORT FOR THE RECTAL TEMPERATURE, AND NO ALARM OCCURRED. THE MODULE'S LIGHT EMITTING DIODE (LED) WAS GREEN. AFTER THE PROCEDURE THE TEAM CYCLED THE POWER, AND THERE WERE NO APPARENT PHANTOM ALARMS. THE MODULE WAS EXCHANGED A FEW DAYS AFTER THE PROCEDURE. THERE WAS NO BLOOD LOSS OR HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233987 ↗
• MalfunctionSep 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE TEMPERATURE MODULE WOULD NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9075427 ↗
• MalfunctionJul 23, 2019Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING FIELD SERVICE INSTALLATION, THE TEMPERATURE MODULE DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8815533 ↗
• MalfunctionJul 1, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TEMPERATURE MODULE WAS CYCLING THROUGH THE LIGHT EMITTING DIODE (LED) LIGHT ON THE MODULE AND SHOWING A "?" ON THE CENTRAL CONTROL MONITOR (CCM). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749777 ↗