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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); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2023
Event Type  malfunction  
Event Description
The customer reported that the iv pole on the trima equipment unexpectedly lowers down.An iv pole safety collar is installed on the device.The issue was discovered during setup.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.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician mechanically adjusted and calibrated the iv pole release mechanism and verified proper operation.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.Correction: a field service engineer adjusted the iv pole release mechanism.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician mechanically adjusted and calibrated the iv pole release mechanism and verified proper operation.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.A field service engineer adjusted the iv pole release mechanism.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an iv pole release mechanism adjustment.
 
Event Description
The customer reported that the iv pole on the trima equipment unexpectedly lowers down.An iv pole safety collar is installed on the device.The issue was discovered during setup.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.
 
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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 Key17226792
MDR Text Key318340125
Report Number1722028-2023-00222
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK180231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2023
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 06/08/2023
Initial Date FDA Received06/29/2023
Supplement Dates Manufacturer Received07/21/2023
Supplement Dates FDA Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2018
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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