Terumo® Advanced Perfusion System 1 816300Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00886799001325), received between Jun 11, 2018 and Sep 22, 2026 — classified as 300 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (98 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 25 most recent of 300 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861414 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  It was reported that during set-up of the device for a cardiopulmonary bypass (CPB) procedure, the Central Control Monitor (CCM) display went blank. 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 50849683 ↗
• MalfunctionSep 15, 2026Inadequate User Interface

  The Field Service Representative (FSR) reported that during preventative maintenance (PM) of the device, the Central Control Monitor (CCM) mouse on the touchscreen was off about half of an inch. Recalibration worked for a while, then it drifted again an inch off but was able to be recalibrated again and drifted again. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773105 ↗
• MalfunctionSep 4, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614448 ↗
• MalfunctionAug 6, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161574 ↗
• MalfunctionMar 25, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) WAS STUCK ON THE BOOT-UP SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691584 ↗
• MalfunctionMar 23, 2026Power Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT WHILE USING THE CENTRIFUGAL PUMP TO DRAIN LEFTOVER BLOOD INTO THE RESERVOIR, THE CENTRAL CONTROL MONITOR (CCM) DISPLAY WENT BLANK AND THEN THE CCM REBOOTED. THE PUMP WAS STILL RUNNING DURING THE CCM REBOOT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669043 ↗
• MalfunctionMar 2, 2026Inadequate User Interface

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) TOUCHSCREEN BECAME UNRESPONSIVE. 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 24484509 ↗
• MalfunctionFeb 23, 2026No Display/Image

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAY WAS BLANK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421887 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) WAS TURNED ON WHEN SUDDENLY THE DISPLAY WENT BLANK AND THE PUMP DISPLAYED A 'NO SYSTEM COMPUTER' 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 24241671 ↗
• MalfunctionJan 22, 2026No Display/Image

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) WAS BLANK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152320 ↗
• MalfunctionJan 14, 2026Inadequate User Interface

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) HAD A TOUCHSCREEN ISSUE ON THE LOWER RIGHT PORTION OF THE SCREEN, WHERE THE CURSOR DID NOT MATCH THE TOUCH POINTS, EVEN 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 24070380 ↗
• MalfunctionJan 12, 2026Output 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. ERROR LOGGING IN PROCESS ERROR' 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 24045860 ↗
• MalfunctionDec 22, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SETUP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT DISPLAYED A 'SERVICE GAS SYSTEM' MESSAGE AND THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) WOULD NOT ALLOW CALIBRATION. THERE WAS ALSO A 'BATTERIES HAVE EXCEEDED THEIR 2-YEAR LIFE AND REQUIRE SERVICE' MESSAGE. AFTER RESTARTING THE SYSTEM, IT WORKED NORMALLY. 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 23871359 ↗
• MalfunctionDec 22, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE POWER DOWN WINDOW ON THE CENTRAL CONTROL MONITOR (CCM) WAS BLANK. THE UNIT WAS RESTARTED AND THEN OPERATED AS NORMAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871275 ↗
• MalfunctionDec 19, 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 CENTRAL CONTROL MONITOR (CCM) DISPLAY WENT BLANK, BUT THE FAN WAS STILL RUNNING. 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 23851435 ↗
• MalfunctionDec 19, 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 CENTRAL CONTROL MONITOR (CCM) DISPLAY WENT BLANK, BUT THE INTERNAL FAN WAS STILL RUNNING. 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 23851419 ↗
• MalfunctionDec 18, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SYSTEM COMPUTER NEEDS SERVICE' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844117 ↗
• MalfunctionDec 9, 2025Output 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 'DISK BOOT FAILURE' 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 23759718 ↗
• MalfunctionNov 26, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED AN 'OXYGEN (O2) SENSOR ERROR' MESSAGE. 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 23657412 ↗
• MalfunctionNov 25, 2025Power Problem; Power Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRAL CONTROL MONITOR (CCM) WOULD NOT BOOT UP AND THE FANS WERE NOT RUNNING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648332 ↗
• MalfunctionNov 25, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) WOULD NOT BOOT UP. 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 23647740 ↗
• MalfunctionNov 20, 2025Output 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 'DISK BOOT FAILURE' MESSAGE AT START-UP. 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 23609345 ↗
• MalfunctionNov 20, 2025Crack; Inadequate User Interface; Crack; Inadequate User Interface

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE CENTRAL CONTROL MONITOR (CCM) MONITOR HAD A CRACK THAT PREVENTED HIS FINGER FROM PROPERLY TRACKING AND GOT SIGNIFICANTLY WORSE THE CLOSER TO THE CRACK HE GOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23608932 ↗
• MalfunctionNov 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) HAD A BLACK SCREEN UPON POWER UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543650 ↗