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

Catalog Number 80440

Device Problems Improper or Incorrect Procedure or Method (2017); Microbial Contamination of Device (2303)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 02/20/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: pre-collection and disinfection and in-line diversion sets were utilized for trima devices throughout the study period at (b)(6) sites.Leukoreduction apheresis platelets were collected from the (b)(6) site utilizing pre-collection arm disinfection and in-line diversion sets for trima throughout the study period of january 2010 to december 2013.There were no confirmed septic reactions for (b)(6) during the study period.Investigation is in process.A follow-up report will be provided.Citation: bravo, m., shaz, b.H., kamel, h., vanderpool, s., tomasulo, p., custer, b., and townsend, m.(2015).Detection of bacterial contamination in apheresis platelets: is apheresis technology a factor? transfusion, 55(9), 2113-2122.Doi:10.1111/trf.13107.

Event Description

During a terumo bct review of the transfusion journal article ' detection of bacterial contamination in apheresis platelets: is apheresis technology a factor?' reported that (b)(6) collected apheresis platelets using trima collection devices for a retrospective study.The 262,772 platelet collections were collected atbsi from the study period of november 2008 to february 2014.During the study period, 3 confirmed bacterial transmissions were documented from 43 suspected septic transfusion reaction reports received from hospitals served by ubs centers.One reaction was due to red blood cell (rbc) unit and two were due to platelet units.One confirmed transfusion reaction was from platelet unit collected from a trima.Per the journal article, the following patient information were collected from the 262,772 collections that was performed that the bsi sites:180,867 donors were male, 81,905 donors were female,19,897 donors were age 16-22, 104,247 donors were age 23-49, 106,339 donors were age 50-64, 32,288 donors were aged over 60, 5,136 donors were black, non-hispanic, 38,440 donors were hispanic, 2,864 donors were other, 3,168 donors were asian/pacific islander, 204,395 donors were white, 8,769 donors did not have a race a listed.The customer declined to provide additional information for the investigation such as procedural details, lot information, patient information, and patient outcome.The disposable sets are not available for return because it was discarded by the customer.

Manufacturer Narrative

Per the article, 'reactions induced by platelet transfusions', v.Kiefel explains how severe septic transfusion reactions are considered rare occurrences that can happen after platelet transfusion.The article also states that severity of the reactions can be chills, vomiting,tachycardia, hypotension and in severe cases shock with hyperpyrexia.Root cause: the root cause for the patient reactions is not conclusive.Possible causes for the patient reactions include bacterial contamination from transfused platelets and/or patient diseases tate.Citation:kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35(5), 354-358.Doi:10.1159/000151350.

Manufacturer Narrative

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

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6950160
• MDR Text Key: 89363644
• Report Number: 1722028-2017-00402
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• 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: 10/13/2017

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: 80440
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 01/30/2018; 02/21/2018
• Supplement Dates FDA Received: 02/02/2018; 02/26/2018
• 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): Other