Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM Back to Search Results
Model Number 81000
Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation: a terumo bct technician adjusted the iv pole on the device at the customer site.Investigation is in process, a follow up report will be provided.
 
Event Description
The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.
 
Event Description
The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.
 
Manufacturer Narrative
This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: a terumo bct technician adjusted the iv pole on the device at the customer site.Service was able to confirm the iv pole safety collar was present prior to the reported incident.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no other problems identified related to the reported condition.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related an adjustment of the iv pole button.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer (Section G)
TERUMO BCT
10810 w. collins ave
lakewood CO 80215
Manufacturer Contact
scot hilden
10810 w. collins ave
lakewood, CO 80215
MDR Report Key15015461
MDR Text Key295957769
Report Number1722028-2022-00228
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
BK190332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number81000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2022
Initial Date FDA Received07/14/2022
Supplement Dates Manufacturer Received07/22/2022
Supplement Dates FDA Received08/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-