Terumo® Advanced Perfusion System 1 801041Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Roller Pump (6" Blue). The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets. · Class 2
All models of Terumo Advanced Perfusion System 1 (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886799000540), received between Nov 16, 2018 and Aug 7, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).
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
Device problems
- Display or Visual Feedback Problem1
- Erratic or Intermittent Display1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2019Display 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 LOCAL DISPLAY ON THE ROLLER PUMP WAS BROKEN/BLANK. 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 8868640 ↗MalfunctionNov 16, 2018Erratic or Intermittent Display; Erratic or Intermittent Display
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE PUMP HAD INTERMITTENT DISPLAY OPERATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8078453 ↗
Other Console, Heart-Lung Machine, Cardiopulmonary Bypass devices
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
- MAQUET CARDIOHELP CARDIOHELP-iMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 recalls2 deaths64 reports
- MAQUET CARDIOHELP CARDIOHELP SystemMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS4 recalls18 deaths107 reports
- Terumo® Advanced Perfusion System 1 816300Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass300 reports
- Terumo® Advanced Perfusion System 1 801763Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 death230 reports
- Terumo® Advanced Perfusion System 1 816571Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass230 reports
- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
- Terumo® Advanced Perfusion System 1 5773Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 recall78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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