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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA, RBC + AUTO PAS SET

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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLASMA, RBC + AUTO PAS SET Back to Search Results
Catalog Number 82410
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Root cause : the rdf analysis did not show a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection.Review of the rdf showed a slight delay of cells exiting the lrs chamber at the start of platelet collection.Once the platelets started to exit the lrs chamber, they were collected at the expected platelet concentration.It is possible though not conclusive that the draw pressure too low alerts, which occurred just after the start of the platelet collection, in combination with the flow adjustments temporarily disrupted the steady state of the lrs chamber, causing some wbcs to escape.It cannot be ruled out that this leuko reduction failure is donor related.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The platelet collection is not available for return because it was discarded by the customer.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS PLATELET, PLASMA, RBC + AUTO PAS SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer Contact
steve kern
10810 w. collins ave
lakewood, CO 80215
3032392246
MDR Report Key7154082
MDR Text Key96128423
Report Number1722028-2017-00520
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
BK160116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/29/2017
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 Expiration Date06/01/2019
Device Catalogue Number82410
Device Lot Number1706081130
Other Device ID Number05020583824102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2017
Initial Date FDA Received12/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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