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 Problem Reaction (2414)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: eder et.Al explained that all collections, regardless of device or time frame,utilized inlet-line sample diversion and had an 8-ml sample taken for aerobic culture at least 24 hours after phlebotomy.Approximately 1 in 100,000 distributed platelet components caused definite or probable septic transfusion reactions, based on cases investigated in the american red cross hemovigilance program and some bacterially contaminated platelet-pheresis donations escaped detection (i.E.,false negatives) and continued to cause septic transfusion reactions.Every septic transfusion reaction documented in the american red cross program has implicated apheresis platelet components from donations with false-negative (sampling on day 1) qc culture results at the time of transfusion and through to the end of the incubation period (day 5).Moreover, septic transfusion reactions are often difficult to recognize in patients with complicated underlying illnesses, and delayed reactions occurring 6 to 24 hours after transfusion might not be attributed to the transfusion at all.Eder et.Al also stated that all american red cross regions investigated reported septic transfusion reactions, although the rates of reporting varied, with some regions investigating more suspected septic transfusion reactions than others.However, approximately 11% of reported cases were consistently classified as definite or probable septic transfusion reactions.Investigation is in process.A follow-up report will be provided.Citation:eder, a.F., dy, b.A., demerse, b., wagner, s.J., stramer, s.L., oneill, e.M., & herron, r.M.(2017).Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions.Transfusion, 00.

Event Description

During a terumo bct review of the transfusion journal, ¿apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions¿ researchers, ederet.Al, performed a total of 671,955 trima collections for a 5-year study from january 1, 2010 and december 31, 2014 at several american red cross facilities.Results from the study determined that septic transfusion reactions were caused by three apheresis platelet units from three contaminated trima procedures with negative bacterial cultures.A supplement analysis of the regions that only used trima devices for a consecutive 8-year period from the year of 2007 to 2014 was also performed at several american red cross facilities.Data results from this study indicated that nine cases were reported of definite and probable septic transfusion reactions from trima collections.Data results also indicated that most of the septic reaction were caused by staphylococcus spp.Or streptococcus spp for 80%of trima collections.Clinical criteria in all septic transfusion reactions reported included at least one of the following symptoms typically within 6 hours of transfusion: fever of 398 c or more or a change of at least 28 c from pretransfusion value, rigors, tachycardia greater than 120 beats per minute (bpm) or a change of at least 40 bpm from pretransfusion value, or an increase or decrease of at least 30 mmhg in blood pressure.A definite septic transfusion reaction was defined by clinical criteria associated with a culture-positive residual component and a culture-positive recipient demonstrating the same bacterial isolate, such as determined by antibiotic sensitivity and/or pulsed-field gel electrophoresis, or by clinical criteria in both recipients of proven culture-positive co-components.A probable septic transfusion reaction was defined by clinical criteria and a positive culture on the residual component without matching positive culture results in the recipient or by clinical criteria and matching patient culture results in two different recipients of each co-component that was not cultured after the transfusion.The customer declined to provide additional information for the investigation such as procedural details, lot information, patient information, and patient outcome of the 12 donor reactions.The disposable sets are not available for return because it was discarded by the customer.

Manufacturer Narrative

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.

Manufacturer Narrative

Investigation: 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: root cause for the patient (donor) reactions is not conclusive.Possible causes for the patient reactions include bacterial contamination from transfused platelets and/or patient disease state.Citation:kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35(5), 354-358.Doi:10.1159/000151350.

• 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: 6938727
• MDR Text Key: 89177199
• Report Number: 1722028-2017-00395
• 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: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017

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: 09/15/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 01/30/2018; 02/05/2018
• 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