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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TIRMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
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TERUMO BCT TIRMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM Back to Search Results
Model Number 81000
Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Fell (4014)
Patient Problem Crushing Injury (1797)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation: per the customer, the machine has installed the iv pole guard and the customer informed that they have now placed their machine set up in a different way to avoid injury: first the filter bracket and then the iv pole guard.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a procedure on the trima device, the operator was attempting to move the iv pole down a bit by pressing hard on the iv pole release button.She attempted to move her hand quickly, but the iv pole fell and injured her index finger with the filter bracket.It is unknown if medical intervention was required for this event.Patient id, age and weight are not available at this time.
 
Manufacturer Narrative
Per the customer, the machine has installed the iv pole guard and the customer informed that they have now placed their machine set up in a different way to avoid injury: first the filter bracket and then the iv pole guard.Terumo bct evaluated the device at the customer site.Service was able to confirm the iv pole safety collar was present prior to the reported incident.However, the placement of the iv pole safety collar in relation to the filter bracket created a pinch point that can cause potential injury.The service representative reinstalled the iv pole safety collar so that the filter bracket is above the collar to prevent future potential injuries.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.Correction: an iv pole collar was developed to mitigate the potential for injury between the iv pole and the device.However, it has been identified that the installation placement of the iv pole collar in relation to an accessory creates a new risk for potential for injury.A field action evaluation has been initiated to evaluate the new risk.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a procedure on the trima device, the operator was attempting to move the iv pole down a bit by pressing hard on the iv pole release button.She attempted to move her hand quickly, but the iv pole fell and injured her index finger with the filter bracket.Upon follow-up it was reported that the operator received some scratches and her index finger swelled up.No medical intervention was required for this event and the injury was managed at home with an ice pack.Patient id, age and weight are not available at this time.
 
Manufacturer Narrative
Investigation: per the customer, the machine has installed the iv pole guard and the customer informed that they have now placed their machine set up in a different way to avoid injury: first the filter bracket and then the iv pole guard.Terumo bct evaluated the device at the customer site.Service was able to confirm the iv pole safety collar was present prior to the reported incident.However, the placement of the iv pole safety collar in relation to the filter bracket created a pinch point that can cause potential injury.The service representative reinstalled the iv pole safety collar so that the filter bracket is above the collar to prevent future potential injuries.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.Correction: an iv pole collar was developed to mitigate the potential for injury between the iv pole and the device.However, it has been identified that the installation placement of the iv pole collar in relation to an accessory creates a new risk for potential for injury.A field action evaluation has been initiated to evaluate the new risk.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to the placement of the iv pole safety collar in relation to the filter bracket.
 
Event Description
The customer reported that during a procedure on the trima device, the operator was attempting to move the iv pole down a bit by pressing hard on the iv pole release button.She attempted to move her hand quickly, but the iv pole fell and injured her index finger with the filter bracket.Upon follow-up it was reported that the operator received some scratches and her index finger swelled up.No medical intervention was required for this event and the injury was managed at home with an ice pack.Full patient id: 1.013.651.951 patient age was not provided by the customer.
 
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Brand Name
TIRMA 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 Key12934205
MDR Text Key286664751
Report Number1722028-2021-00374
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583810006
UDI-Public05020583810006
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
BK090003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number81000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2010
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;
Patient SexFemale
Patient Weight70 KG
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