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Trima Accel® 81002Recalls & reported problems

Terumo Bct, Inc. · Automated Blood Collection System · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05020583810020), received between Sep 26, 2018 and Oct 29, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Break1
  • Defective Component1
  • Device Slipped1
  • No Apparent Adverse Event1
  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Patient Involvement2
  • Injury1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 29, 2021Mechanical Problem; Mechanical Problem; Device Slipped

    THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12721425 ↗
  • MalfunctionFeb 1, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11262772 ↗
  • InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER DID NOT RESPOND TO MULTIPLE ATTEMPTS TO OBTAIN THE PATIENT INFORMATION OR WHETHER MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Patient problems: Injury

    MAUDE report 10396277 ↗
  • MalfunctionNov 29, 2018No Apparent Adverse Event; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THE WBC COUNT IS NOT AVAILABLE AT THIS TIME. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT. THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 8117845 ↗
  • MalfunctionSep 26, 2018Break; Positioning Failure; Unintended System Motion; Defective Component; Unintended System Motion; Defective Component

    DURING A SERVICE CALL AT THE CUSTOMER¿S SITE, THE TERUMO BCT SERVICE TECHNICIAN DISCOVERED THE IV POLE ON THE TRIMA EQUIPMENT WOULD NOT STAY UP. THE SERVICE TECHNICIAN REPORTED THE CUSTOMER HAD BEEN USING TAPE TO HOLD IT IN PLACE. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS DISCOVERED, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 7912429 ↗

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.