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
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- Trima Accel® 82446Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic1 death300 reports
- Trima Accel® 81000Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic150 reports
- Spectra Optia® 12220Terumo Bct, Inc. · Separator, Automated, Blood Cell, Diagnostic14 deaths147 reports
- Spectra Optia® 12320Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic2 deaths119 reports
- Trima Accel® 80400Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic109 reports
- Spectra Optia® 10310Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic6 deaths103 reports
- HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM PCS-300-USHaemonetics Corporation · Separator, automated, blood cell, diagnostic18 deaths101 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.