Terumo® Advanced Perfusion System 1 802112Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00886799000724), received between May 18, 2018 and Nov 26, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Incorrect, 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, THERE WAS A FIVE SECOND DELAY BETWEEN THE CHANGE IN PRESSURE AND PRESSURE READING BEING DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). THE TEAM REPLACED THE PRESSURE TRANSDUCER DURING TROUBLESHOOTING, BUT THE ISSUE REMAINED. THE SYSTEM WAS POWER CYCLED AND THE PRESSURE READINGS ON THE CCM BEGAN UPDATING AT THE EXPECTED SPEED AND 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 23662957 ↗
• MalfunctionNov 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ARTERIAL AND CARDIOPLEGIA PRESSURES WERE SHOWING QUESTION MARKS. THE PRESSURES CAME BACK ON BUT THEN HAD AN ISSUE TWO MORE TIMES BEFORE THEY CAME BACK AGAIN AND THE CASE WAS CONTINUED WITHOUT INCIDENT. 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 23596270 ↗
• MalfunctionOct 15, 2025Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), A PRESSURE ISSUE CAUSED THE CENTRIFUGAL MOTOR TO COAST. 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 23293997 ↗
• MalfunctionOct 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PRESSURE MODULE WAS INACCURATE. 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 17909097 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER STATED THAT THE HLM PRESSURE DISPLAY WAS READING 999 MILLIMETERS OF MERCURY (MMHG). IT IS UNCLEAR WHICH PRESSURE, ARTERIAL, CARDIOPLEGIA, OR VACUUM WAS AFFECTED. ADDITIONALLY, IT IS NOT KNOWN WHAT SAFETY CONNECTION, OR IF ANY SAFETY CONNECTION, WAS ATTACHED TO THIS PRESSURE. LASTLY, IT IS UNKNOWN WHAT ROLLER PUMPS WERE ATTACHED WITH THIS PRESSURE FOR A SAFETY RESPONSE. THERE WERE ATTEMPTS MADE TO OBTAIN INFORMATION ON DELAY OF THE PROCEDURE, BLOOD LOSS, OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THESE ATTEMPTS WERE UNSUCCESSFUL. THE USER STATED THAT THEY REPLACED THE PRESSURE MODULE, BUT THIS DID NOT MITIGATE THE 999 ON THE SCREEN.

  Patient problems: Insufficient Information

  MAUDE report 17391940 ↗
• MalfunctionJul 24, 2023Incorrect, 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 CENTRAL CONTROL MONITOR (CCM) DISPLAYED 999 FOR PRESSURE. 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 17383853 ↗
• MalfunctionOct 18, 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 CARDIOPLEGIA (CPG) PRESSURE 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 15626553 ↗
• MalfunctionMar 16, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PRESSURE VALUES WERE NOT DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM) AFTER CALIBRATION. 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 11499202 ↗
• MalfunctionMar 5, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PRESSURE ALERT KEPT ALARMING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM STATED THAT ON (B)(6) 2020 DURING A CPB PROCEDURE THEY WERE HEARING AN AUDIBLE LEVEL ALERT MESSAGE, BUT THAT THERE WAS NO MESSAGING IN THE MESSAGING AREA OF THE CENTRAL CONTROL MONITOR (CCM) OR THE ALARM/ALERT AREA OF THE SECONDARY SCREEN. THEY ALSO STATED THAT THE LEVEL SENSOR PAD WAS NOT PROPERLY ATTACHED TO THEIR ROUNDED MEDTRONIC RESERVOIR. THE LOG DATA CONFIRMS THAT A LEVEL SENSOR ERROR OCCURRED. THIS DID NOT DELAY THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT. THE CASE CONTINUED WITHOUT ISSUE. NOTED IS THAT THERE WAS A HIGH PRESSURE ALERT - DUE TO SPIKES IN THE CARDIOPLEGIA (CPG) LINE, CAN HAPPEN IN NORMAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793348 ↗
• MalfunctionApr 11, 2019Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PRESSURE CHANNEL WAS ALARMING EVEN THOUGH IT WAS READING "0". THEY CHANGED TO USING A MEDTRONIC PRESSURE MONITOR TO COMPLETE THE CASE. 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 8503529 ↗
• MalfunctionOct 4, 2018Communication or Transmission Problem; Communication or Transmission Problem

  UPON RECEIPT OF THE DEVICE, THE STATUS OF THE PRESSURE MODULE REMAINED ORANGE STATUS INSTEAD OF CHANGING TO GREEN WHEN THE PUMP WAS ONLINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7934954 ↗
• MalfunctionMay 18, 2018Out-Of-Box Failure; Device Displays Incorrect Message; Out-Of-Box Failure; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE PRESSURE POD WAS CAUSING A "?" TO BE DISPLAYED ON THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7526190 ↗