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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 01/09/2024
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Event Description
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.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10 (h.11) and corrected d.4.Investigation: : a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The service technician found that the screw was out of adjustment.Adjusted the push button and verified iv pole 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 further issues related to the reported condition identified.Correction: a field service engineer adjusted the iv pole push button.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an adjustment of the iv pole locking nut and screw.
 
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.Correction: a field service engineer adjusted the iv pole push button.Investigation is in process.A follow-up report will be provided.
 
Event Description
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.
 
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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 Key18624589
MDR Text Key335086997
Report Number1722028-2024-00038
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK150321
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,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2024
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
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2016
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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