Terumo® Advanced Perfusion System 1 802110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886799000700), received between Apr 25, 2019 and Jun 19, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570876 ↗
• MalfunctionSep 1, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE AIR BUBBLE DETECTOR (ABD) DID NOT WORK. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339432 ↗
• MalfunctionNov 10, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE AIR BUBBLE DETECTOR (ABD) MODULE LIGHT EMITTING DIODE (LED) FLASHED ORANGE AND RED AND THE PERFUSION SCREEN INTERMITTENTLY DISPLAYED A QUESTION MARK OVER THE ABD ICON. 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 12791302 ↗
• MalfunctionOct 14, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE AIR BUBBLE DETECTOR (ABD) MODULE HAD FAILED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631875 ↗
• MalfunctionNov 13, 2020Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE HEART LUNG MACHINE, THE AIR BUBBLE DETECTOR (ABD) FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10836267 ↗
• MalfunctionApr 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE RED EMITTING DIODE (LED) INDICATOR ON THE AIR BUBBLE DETECTOR (ABD) WAS NOT BLINKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8548825 ↗