Terumo® Advanced Perfusion System 1 801764Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00886799000663), received between Jan 31, 2019 and Mar 18, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Battery Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) DISPLAYED AN 'EXCEEDED THE 2 YEARS' SERVICE LIFE OF YOUR BATTERY' MESSAGE. THE HLM 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 24626312 ↗
• MalfunctionJan 5, 2026Thermal Decomposition of Device

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE ISSUE OCCURRED DURING FIELD INSTALLATION OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961490 ↗
• MalfunctionSep 5, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) BATTERY WAS NOT CHARGING. THE HLM WAS USED FOR THE REMAINDER OF THE CASE WITHOUT BATTERY BACKUP. 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 20150851 ↗
• MalfunctionMay 28, 2024Device Alarm System; Device Alarm System

  PER CLINICAL REVIEW: THE TEAM AT THE USER FACILITY REPORTED A PROBLEM WITH THE HEART LUNG MACHINE (HLM) WHILE ON CARDIOPULMONARY BYPASS, DESCRIBED AS 'ALARM OCCURRED' WITH AN EXPLANATION THAT THE ALARM OCCURRED THREE TIMES TOWARDS THE END OF BYPASS, WITH NO MESSAGE APPEARING ON THE MAIN ALARM MESSAGE SCREEN, AND THE USER WAS UNABLE TO CHECK THE AUX TAB AT THE TIME OF THE OCCURRENCE TO READ THE 'MESSAGES' TAB, WHICH WOULD HAVE INDICATED WHAT THE ALARM WAS. THERE ARE SEVERAL SITUATIONS THAT CAN CAUSE THIS BEHAVIOR, NAMELY AN ALARM EVENT OCCURRING AND SUBSEQUENTLY RESETTING SO FAST THAT THE MESSAGE DOES NOT APPEAR ON THE MAIN SCREEN, BUT ONLY APPEARS ON THE 'MESSAGE' SCREEN IN THE AUX TAB. THE MOST COMMON ARE 'BACKFLOW' AND 'LEVEL NOT ATTACHED'. IT IS THOUGHT THE ALARMS WERE ONE OF THESE POSSIBILITIES, AND NOT A FALSE ALARM, AND NORMAL HLM BEHAVIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19411590 ↗
• MalfunctionJan 31, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE POWER MANAGER OF THE HEART LUNG MACHINE (HLM) WAS NOT CHARGING THE BATTERY AND WAS NOT DISPLAYING THE CHARGING VOLT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616317 ↗
• MalfunctionJan 24, 2024Output 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 'SYSTEM COMPUTER NEEDS SERVICE' MESSAGE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570360 ↗
• MalfunctionJul 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) WORKED ON BATTERY FOR LESS THAN 60 MINUTES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 15-MINUTE DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM REPORTED AN ISSUE WITH THEIR HLM DURING SET-UP. SPECIFICALLY, THE TEAM REPORTED THAT THE BATTERY BACKUP HAD LESS THAN 60 MINUTE OF CHARGE LIFE. AS A RESULT, THE TEAM HAD TO OBTAIN A BACKUP HLM, WHICH RESULTED IN AN APPROXIMATE 15-MINUTE DELAY TO THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, THERE WAS NO BLOOD LOSS AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300790 ↗
• MalfunctionFeb 22, 2023Failure to Power Up; Failure to Power Up

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE NETWORK INTERFACE CARD (NIC) BOARD DID NOT SEND POWER TO CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418187 ↗
• MalfunctionOct 4, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) HAD NO BACKUP BATTERY AND THE BATTERIES WERE DEFECTIVE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 MINUTE DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE USER REPORTED USING THE HLM PRIOR TO CPB, AT WHICH TIME THEY OBSERVED THERE WAS NO BATTERY BACK-UP. THEY STATED THE BATTERIES WERE DEFECTIVE AND NEEDED TO BE REPLACED. THIS OCCURRED DURING SET-UP, THERE WAS A DELAY TO THE SURGICAL PROCEDURE OF APPROXIMATELY 30 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO BLOOD LOSS AND INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538808 ↗
• MalfunctionAug 10, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE HEART LUNG MACHINE (HLM) SOLID STATE RELAY FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203518 ↗
• MalfunctionAug 2, 2022Failure to Power Up; Failure to Power Up

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE POWER SUPPLY FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148649 ↗
• MalfunctionApr 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  UPON THE RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE HEART LUNG MACHINE (HLM) WAS RUNNING ON BATTERY POWER EVEN WHEN PLUGGED INTO ALTERNATING CURRENT (AC) POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251340 ↗
• MalfunctionJun 30, 2021Battery Problem; Output Problem; Battery Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BATTERY WAS DISCHARGING AT A VERY FAST RATE AND WOULD ONLY LAST ABOUT FIVE MINUTES. 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 12094894 ↗
• MalfunctionApr 22, 2021Unintended Power Up; Charging Problem; Unintended Power Up; Charging Problem

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT UNIT AUTOMATICALLY POWERED ON WITHOUT CHARGING OR BEING CONNECTED TO A POWER SOURCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710073 ↗
• MalfunctionFeb 17, 2021Failure to Run on Battery

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT WOULD NOT OPERATE ON BATTERY. 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 11340036 ↗
• MalfunctionDec 18, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE POWER SUPPLY ON THE HEART LUNG MACHINE (HLM) FAILED AND THE BATTERIES WERE NOT CHARGING. 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 11038334 ↗
• MalfunctionDec 20, 2019Battery Problem; Battery Problem

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE BATTERY WAS NOT PASSING RELEASE TESTING AND WAS NOT HOLDING THE CHARGE AFTER OVER 12 HOURS OF CHARGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9502790 ↗
• MalfunctionDec 20, 2019Battery Problem; Battery Problem

  UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE BATTERY WAS NOT PASSING THE RELEASE TEST OR HOLDING A CHARGE AFTER OVER 12 HOURS OF CHARGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9502764 ↗
• MalfunctionSep 10, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE UNIT DISPLAYED A "BATTERY NEEDS SERVICE, FULL BATTERY BACK UP NOT AVAILABLE" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8982943 ↗
• MalfunctionMay 16, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE BATTERIES WERE CHARGING FULLY BUT NOT CAPABLE TO STORE THE CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8615108 ↗
• MalfunctionApr 3, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING INSTALLATION OF THE DEVICE, THE BATTERIES WERE NOT CHARGE AND WERE NOT HOLDING A CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8480020 ↗
• MalfunctionJan 31, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING INSTALLATION OF THE HEART LUNG MACHINE (HLM), THE BATTERIES WERE DEPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8293607 ↗