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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM Back to Search Results
Model Number 81000
Device Problems Mechanical Problem (1384); Device Slipped (1584)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2022
Event Type  malfunction  
Event Description
The customer reported that the iv pole cannot be fixed if it is in the middle position and falls unexpectedly.It is unknown at this time if there were any patients involved or medical intervention required for the iv pole not staying up.No injury was reported.
 
Manufacturer Narrative
Investigation: a terumo bct product support representative checked out the machine at the customer site and confirmed the reported condition.The technician adjusted the iv pole and fixed the release button.Investigation is in process.A follow up report will be provided.
 
Manufacturer Narrative
Investigation: a terumo bct product support representative checked out the machine at the customer site and confirmed the reported condition.The technician adjusted the iv pole and fixed the release button.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 issues related to the reported condition identified.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be an inappropriate gap between the iv pole and release button resulting from aging and repeated moving of the side panel.
 
Event Description
The customer reported that the iv pole cannot be fixed if it is in the middle position and falls unexpectedly.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.
 
Event Description
The customer reported that the iv pole cannot be fixed if it is in the middle position and falls unexpectedly.It is unknown at this time if there were any patients involved or medical intervention required for the iv pole not staying up.No injury was reported.
 
Manufacturer Narrative
This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: a terumo bct product support representative checked out the machine at the customer site and confirmed the reported condition.The technician adjusted the iv pole and fixed the release button.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 issues related to the reported condition identified.Investigation is in process.A follow up report will be provided.
 
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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 Key14397628
MDR Text Key300142491
Report Number1722028-2022-00151
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
BK150269
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,Followup
Report Date 05/13/2022
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 04/18/2022
Initial Date FDA Received05/13/2022
Supplement Dates Manufacturer Received06/20/2022
07/06/2022
Supplement Dates FDA Received07/01/2022
07/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2015
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;
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