MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA SET

Catalog Number 000000000000080300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 06/25/2015

Event Type  Injury  

Event Description

The customer reported an allergic reaction in the recipient of platelet products that were collected on a trima system.The patient developed uticaria and welts and was treated with an ampule of fenistil, an ampule of tavegil, and 100mg of sdh.The customer reported the reaction as unproblematic and stated that the patient is well.The customer reported other similar reactions on different patients.All the platelet products came from different donors.Due to eu personal data protection laws, the patient weight is not available from the customer.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable set was unavailable for specific root cause analysis.It is possible that the patient exhibited an allergic reaction due to their current physiological condition,associated with the transfusion process, which is unknown to (b)(4).Based on the available information and review of the trima collection procedures through run data file analysis, there were no reported donor reactions, which would have occurred if the reactions were related to the additives because the donor would have received some during the course of the procedure.There were no other reported complaints from any other centers for donations of transfused blood products collected by the trima system with the indicated disposable lot numbers mentioned in the complaint.Major contributors for a recipient reaction to a transfused product include several parameters that are not related to terumo products including: the blood product storage conditions prior to transfusion, cross-matching of the blood product, and the recipient patient physiology.Based on the above information, it is highly unlikely that the events described are related to the trima products used to collected blood components.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: the run data file (rdf) was analyzed for the platelet collection.Review of the run data file showed a successful platelet collection with no unusual alerts or remarkable events during the procedure.Signals showed that platelets were collected as expected, the platelet concentration was consistent throughout the collection and donor rinseback was performed successfully.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 4947524
• MDR Text Key: 6638606
• Report Number: 1722028-2015-00460
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2015

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 Expiration Date: 02/01/2017
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 02Y1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2015; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• 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: 79 YR