Trima Accel® 81000Recalls & reported problems
Terumo Bct, Inc. · Automated Blood Collection System · Class 2
Quick summary
This Terumo Trima Accel automated blood collection and separation system is used to collect blood components. Its 150 adverse event reports include no injuries and no deaths, and most describe the device slipping or moving unexpectedly, such as its IV pole lowering on its own. None were reported in the past 12 months, down from 12 before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 150
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 05020583810006), received between Aug 17, 2018 and Dec 30, 2024 — classified as 150 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (129 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem129
- Device Slipped118
- Insufficient Device Problem Information55
- Unintended Movement22
- No Apparent Adverse Event8
- Adverse Event Without Identified Device or Use Problem4
- Loose or Intermittent Connection3
- Mechanics Altered3
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- No Patient Involvement31
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Crushing Injury1
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 21036029 ↗MalfunctionDec 26, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS INSTALLED. 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 21019404 ↗MalfunctionDec 26, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 21018795 ↗MalfunctionDec 23, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 21000998 ↗MalfunctionDec 19, 2024Device Slipped; Insufficient Device Problem Information; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS INSTALLED. 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 20978215 ↗MalfunctionDec 19, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS INSTALLED. 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 20977997 ↗MalfunctionDec 17, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20953847 ↗MalfunctionDec 17, 2024Device Slipped; Insufficient Device Problem Information; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20953612 ↗MalfunctionNov 21, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20747674 ↗MalfunctionNov 18, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS INSTALLED. 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 20707679 ↗MalfunctionNov 17, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED AT THE TIME OF THIS EVENT. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20702719 ↗MalfunctionNov 14, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE WAS NOT INSTALLED ON THIS DEVICE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20684759 ↗MalfunctionOct 31, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20578571 ↗MalfunctionOct 31, 2024Device Slipped; Insufficient Device Problem Information; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. IV POLE CLAMP WAS INSTALLED. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 20578510 ↗MalfunctionOct 14, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED AT THE TIME OF THIS EVENT. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20441391 ↗MalfunctionOct 4, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369866 ↗MalfunctionSep 17, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS INSTALLED. 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 20237057 ↗MalfunctionAug 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS INSTALLED. 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 19942755 ↗MalfunctionJul 18, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. PER THE CUSTOMER, THE IV POLE CLAMP WAS INSTALLED. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19772968 ↗MalfunctionJul 5, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 19680779 ↗MalfunctionJun 20, 2024Device Slipped; Insufficient Device Problem Information; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA ACCEL EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED AT THE TIME OF THIS EVENT. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT THEREFORE, NO PATIENT INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19575804 ↗MalfunctionJun 10, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS NOT INSTALLED. 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 19499395 ↗MalfunctionMay 23, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. 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 19383568 ↗MalfunctionApr 26, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS NOT INSTALLED. 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 19193459 ↗MalfunctionApr 19, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. IV POLE CLAMP WAS INSTALLED. 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 19144163 ↗
Other Separator, automated, blood cell, diagnostic devices
- Trima Accel® 82406Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic470 reports
- Trima Accel® 82446Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic1 death300 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
- Amicus MNC Apheresis Kit - Double Needle X6R2326Fresenius Kabi AG · Separator, Automated, Blood Cell, Diagnostic2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.