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Trima Accel® 80500Recalls & reported problems

Terumo Bct, Inc. · Disposable Tubing Sets, RBC, Plasma Set · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05020583805002), received between Nov 22, 2019 and Nov 22, 2019 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Therapeutic or Diagnostic Output Failure1
  • Use of Device Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 22, 2019Use of Device Problem; Use of Device Problem; Therapeutic or Diagnostic Output Failure

    THE CUSTOMER REPORTED THAT DURING SETUP FOR A PROCEDURE ON THE TRIMA DEVICE DURING THE TUBING SET TEST, THEY RECEIVED ALARM (61) "AIR REMOVAL FAILURE - PRESSURE DETECTED DURING BAG EVACUATION ENDING RUN". PER THE OPERATOR THE BAG WAS CLAMPED A LITTLE LATE. THE SET WAS REMOVED AND NOT USED. THE DONOR WAS MOVED TO ANOTHER DEVICE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 9365216 ↗

Other Separator, automated, blood cell, diagnostic devices

All Separator, automated, blood cell, diagnostic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.