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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 3810002
Device Problems Mechanical Problem (1384); Device Slipped (1584); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.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: the service representative adjusted the screw on the left side of the device so it would not hit the iv pole release.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be the need for adjusting the screw on the left side of the device.
 
Event Description
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.
 
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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 Key18103661
MDR Text Key327754939
Report Number1722028-2023-00369
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK190332
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 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3810002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
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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