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

Catalog Number 80370

Device Problems Device Operational Issue (2914); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Urticaria (2278)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the patient was a recipient of a platelet transfusion derived using the isoplate research protocol.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 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 solucortef via iv.Per the customer, the patient recovered to baseline prior to the transfusion.The customer declined to provide patient's 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

This report is being filed to provide additional information.Investigation: 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) to systemic reactions such as bronchoconstriction.According to literature review, possible reasons 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.Root cause: a definitive root cause for the patient's transfusion reaction could not be determined.Based on customer's statements about the allergic reaction and the literature review, possible causes for the patient's reaction include patient sensitivity to transfused platelet blood product and/or patient's sensitivity to histamines that could be generated during platelet 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.

• 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 Key: 6826898
• MDR Text Key: 83869294
• Report Number: 1722028-2017-00339
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160116
• Number of Events Reported: 1
• 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 Number: 80370
• Other Device ID Number: 05020583803701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 09/18/2017; 10/25/2017
• Supplement Dates FDA Received: 09/22/2017; 11/06/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR