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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Manufacturer Narrative
A terumo bct service technician checked out the machine at the customer site.The service technician cleaned and adjusted the device, and verified the report of the issue with the iv pole.The pole was cleaned and the clamp was adjusted.The clamp was verified to be in proper operation and released back to the customer.Investigation is in process, a follow-up report will be provided.
 
Event Description
Customer reported the iv pole will not stay up.Iv pole clamp is in place.There was not a patient involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.No injury occurred.
 
Event Description
Customer reported the iv pole will not stay up.Iv pole clamp is in place.There was not a patient involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.No injury occurred.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site.The service technician cleaned and adjusted the device, and verified the report of the issue with the iv pole.The pole was cleaned and the clamp was adjusted.The clamp was verified to be in proper operation and released back to the customer.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in process, a follow-up report will be provided.
 
Event Description
Customer reported the iv pole will not stay up.Iv pole clamp is in place.There was not a patient involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.No injury occurred.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site.The service technician cleaned and adjusted the device, and verified the report of the issue with the iv pole.The pole was cleaned and the clamp was adjusted.The clamp was verified to be in proper operation and released back to the customer.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 related to the need for a clamp adjustment.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site.The service technician cleaned and adjusted the device, and verified the report of the issue with the iv pole.The pole was cleaned and the clamp was adjusted.The clamp was verified to be in proper operation and released back to the customer.The device serial number history report indicates no further related issues have been reported for this device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for a clamp adjustment.
 
Event Description
Customer reported the iv pole will not stay up.Iv pole clamp is in place.There was not a patient involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.No injury occurred.
 
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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 Key14576883
MDR Text Key301823287
Report Number1722028-2022-00176
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,Followup,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
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 Received07/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2006
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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