Terumo® Advanced Perfusion System 1 816571Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00886799001370), received between Jun 20, 2018 and Sep 23, 2026 — classified as 230 malfunctions.

The most frequently reported specific device problem is “Output Problem” (86 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Output Problem

  It was reported that during set-up of the device for a cardiopulmonary bypass (CPB) procedure, the roller pump displayed a 'Stopped: Motor error and service pump' 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 50869924 ↗
• MalfunctionAug 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508241 ↗
• MalfunctionAug 6, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168025 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP GAVE A 'BELT SLIP' ERROR. THE TEAM USED IT FOR THE REMAINDER OF THE CASE AS IS. 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 24731309 ↗
• MalfunctionMar 9, 2026Pumping Stopped

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP STOPPED WORKING. THE PERFUSIONIST RESTARTED THE ROLLER PUMP 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 24552253 ↗
• MalfunctionMar 5, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP HAD A BELT SLIP ERROR. 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 24526145 ↗
• MalfunctionFeb 23, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP DISPLAY WAS BLANK. THE TEAM COULD CONTROL THE ROLLER PUMP FROM THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421834 ↗
• MalfunctionFeb 19, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP STOPPED WORKING AND AN ERROR MESSAGE, POSSIBLY STATING 'SERVICE NEEDED', WAS DISPLAYED QUICKLY THEN WENT AWAY. THE PERFUSIONIST RESTARTED THE PUMP AND THE ISSUE RESOLVED. THE TEAM USED THE ROLLER PUMP 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 24389807 ↗
• MalfunctionFeb 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA ROLLER PUMP DISPLAY WAS BLANK WITH NO BACKLIGHT PRESENT. THE TEAM COULD STILL CONTROL THE PUMP FROM THE LOCAL CONTROLS ON THE PUMP HEAD AND THE CENTRAL CONTROL MONITOR (CCM) TOUCH SCREEN. THE MACHINE WAS RESTARTED, THE PUMP HEAD WAS UNPLUGGED THEN PLUGGED BACK IN, BUT THE ISSUE REMAINED. 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 24273644 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP WAS EXCHANGED WITH A SUCKER PUMP, BUT THE BUTTONS WERE NOT RESPONDING. THE TEAM WAS ABLE TO TURN THE PUMP ON WITH THE CENTRAL CONTROL MONITOR (CCM) CONTROLS. 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 24241691 ↗
• MalfunctionJan 30, 2026Inadequate User Interface

  IT WAS REPORTED THAT THE POWER BUTTON ON THE ROLLER PUMP LOCAL DISPLAY WAS NOT WORKING. THE ROLLER PUMP POWER WORKED BUT ONLY WHEN CONTROLLED BY THE CENTRAL CONTROL MONITOR (CCM). 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 24223073 ↗
• MalfunctionJan 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP DISPLAY DID NOT TURN ON BUT THE PUMP WAS STILL FUNCTIONAL AND ABLE TO BE CONTROLLED BY THE CENTRAL CONTROL MONITOR (CCM). AFTER MULTIPLE ATTEMPTS TO TURN THE DISPLAY ON, THE TEAM PHYSICALLY AGITATED IT AND THE ISSUE RESOLVED. THERE WAS NO DELAY, AND NO REPORTED CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24222861 ↗
• MalfunctionDec 19, 2025Output Problem; Power Problem; Output Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ARTERIAL ROLLER PUMP STOPPED TWICE, ONLY DISPLAYING A 'SERVICE PUMP' MESSAGE THE SECOND OCCURRENCE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS AN UNKNOWN DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857799 ↗
• MalfunctionDec 18, 2025Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT AS A RESULT OF THE ISSUE; 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844144 ↗
• MalfunctionDec 16, 2025Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT CARDIOPLEGIA PUMP DISPLAYED A 'BELT SLIP' MESSAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818280 ↗
• MalfunctionNov 21, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP DISPLAYED A 'SERVICE PUMP' 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 23617553 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ARTERIAL ROLLER PUMP HEAD SCREEN WENT BLACK. IT STILL FUNCTIONED OTHERWISE, AND THE FLOW STILL APPEARED AND COULD BE CONTROLLED 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 23480139 ↗
• MalfunctionOct 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP DISPLAY WENT BLANK AND THEN CAME BACK ON WHEN IT WAS TAPPED. 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 23353747 ↗
• MalfunctionOct 16, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP TEMPORARILY LOST POWER. THE TEAM ADJUSTED/MOVED THE CABLE IN THE BACK 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 23311154 ↗
• MalfunctionSep 15, 2025Break; Break

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE ROLLER PUMP LID WAS BROKEN AND THE MAGNET WAS MISSING FROM THE LID. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057130 ↗
• MalfunctionSep 2, 2025Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP INTERMITTENTLY WOULD NOT TURN ON WHEN THE SYSTEM WAS POWERED ON. 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 22939690 ↗
• MalfunctionAug 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP DISPLAY WAS NOT WORKING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891535 ↗
• MalfunctionAug 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, SOME OF THE ROLLER PUMP PIXELS WERE NOT ILLUMINATING MAKING IT DIFFICULT TO READ. THE PUMP COULD STILL BE CONTROLLED LOCALLY AND WITH THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864968 ↗
• MalfunctionAug 18, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP WOULD NOT POWER ON. 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 22829850 ↗
• MalfunctionAug 14, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP DISPLAY WAS NOT 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 22805137 ↗