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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, SAMPLER, AUTO PAS, MULTIPLAS

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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, SAMPLER, AUTO PAS, MULTIPLAS Back to Search Results
Catalog Number 80370
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Itching Sensation (1943); Urticaria (2278)
Event Date 01/28/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: per the customer, the patient was a recipient of a platelet transfusion derived using the isoplate research protocol.According to the aabb technical manual, 16th edition, pages 195-197, adverse reactions seen at the time of donation or those reported later average about 3.5%.The trima accel operator¿s manual instructs the operator to be aware of possible adverse effects and how to manage them.Investigation is in process.A follow-up report will be provided.
 
Event Description
Upon review of a patient's chart by the clinical research associate at the customer's site, it was discovered that during a clinical research study, a patient experienced a mild transfusion reaction.The patient developed hives and complained of itching.Per attending physician's order, the patient was given hydrocortisone via iv.Per the customer, the patient recovered to baseline prior to the transfusion.The customer declined to provide patient weight.The trima accel disposable set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is still in process.A follow-up report will be provided.
 
Manufacturer Narrative
Per literature review, "reactions induced by platelet transfusions," allergic reactions occur with a frequency between 0.09% to 21% of patients that receive platelet transfusions.The article also states that allergic reactions are variable in severity and can display as skin manifestations (hives and itching) to systemic reactions such as bronchoconstriction,hypotensive reactions and shock.Root cause: a definitive root cause for the recipient's reaction could not be determined.Possible causes for allergic reactions related to platelet transfusions include ige and igg antibodies in the transfusion recipient against plasma proteins in the blood product or transfusion of cytokines and histamines generated in the platelet product during blood product preparation and storage.Citation:kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35(5), 354¿358.Http://doi.Org/10.1159/000151350.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS PLATELET, SAMPLER, AUTO PAS, MULTIPLAS
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer Contact
steve kern
10810 w. collins ave
lakewood, CO 80215
3032392246
MDR Report Key6826899
MDR Text Key83876464
Report Number1722028-2017-00340
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK160116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number80370
Other Device ID Number05020583803701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2017
Initial Date FDA Received08/29/2017
Supplement Dates Manufacturer Received09/18/2017
12/12/2017
Supplement Dates FDA Received09/22/2017
12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age73 YR
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