Terumo® Advanced Perfusion System 1 5785Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886799000045), received between Mar 26, 2024 and Oct 29, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 25, 2020Class IITerminated

   Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

   Z-2960-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Device Alarm System; Device Alarm System

  PER CLINICAL REVIEW: ON (B)(6) 2024, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB) WHEREBY AN AIR BUBBLE DETECTOR (ABD) ALARM OCCURRED EVEN WHEN IT WAS TURNED OFF. ACCORDING TO THE USER, WHEN THE AIR SENSOR WAS ATTACHED TO THE CEREBRAL PERFUSION LINE, THE AIR ALARM OCCURRED EVEN WHEN IT WAS OFF. IT OCCURRED WHEN THE CEREBRAL PERFUSION LINE WAS CONNECTED TO THE OPERATING FIELD CIRCUIT AND PRIMING WAS PERFORMED. THEY FINISHED THE CASE WITHOUT CHANGING OUT THE ABD. THERE WAS NO DELAY TO THE PROCEDURE, NO BLOOD LOSS, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561918 ↗
• MalfunctionMar 26, 2024Device Alarm System; Device Alarm System

  PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER NOTED THAT THE AIR BUBBLE DETECTOR (ABD) TURNED OFF, BUT AN ALARM CONTINUED TO SOUND. THIS OCCURRED DURING DEEP HYPOTHERMIC CIRCULATORY ARREST (DHCA), WHILE THE USER WAS DELIVERING SELECTIVE CEREBRAL PERFUSION TO THE PATIENT. THERE WAS NO CASE DELAY, SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND BLOOD LOSS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979322 ↗