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 No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: in the article, eder et.Al explained the collection of apheresis platelets were collected from january 1, 2007 to december 31, 2014.The american red cross distributed 6,270,087 apheresis platelet units collected from volunteer donors at 36 regional blood centers.All collections utilized inlet-line sample diversion removing the initial volume of collection before drawing into the collection bag.All regions implemented a standard, primary skin prep in the year 2009.The study design and methods that was used on the 671,955 trima collections performed from january 1, 2010 to december 31, 2014 was that the american red cross blood centers inoculated 8 ml from each apheresis platelet donation into an aerobic culture bottle at least 24 hours after collection.Culture incubation was continued through the end of the 5-day product shelf life or until indication of a positive (growth) signal.Platelet products were released for distribution if the donation was culture negative after a minimum of 12 hours of incubation.A confirmed-positive result was defined as a subsequent positive culture result for the platelet component or co-component, and a false-positive (unconfirmed) result was defined as a positive bottle signal with bacteria identified in the culture bottle but a negative result on subsequent culture of the component or co-component.According to eder et.Al, several factors that increase the sensitivity of bacterial culture, such as delayed primary or secondary sampling after day 1 for culture before expiration of the unit on day 5 or day 7, increasing the volume of sample taken for culture, or using an anaerobic bottle as well as an aerobic bottle for culture.Interventions to decrease contamination from the skin during phlebotomy have also been well described, such as using inlet-line sample diversion and optimalantecubital disinfection methods.When these variables are held constant by standard practices, however, other factors are likely to contribute to the observed differences in bacterial detection rates.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., and herron, r.M.(2017).Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions.

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 5-year study between january 1, 2010 and december 31, 2014 at several american red cross facilities.A total of 671,955 trima collections were sampled for bacterial culture before manufacture into one to three apheresis platelet components.Seventy-five (75) out of 671,955 donations that were collected on the trima during the 5-year study period confirmed positive bacterial cultures.According to eder et.Al, most (73%) of the bacteria detected were in the trima collections were staphylococcus spp.Or streptococcus spp.A supplement analysis of the regions that only used trima devices for a consecutive 8-year period from the year 2007 to 2014 was also performed at several american red cross facilities and found that in the single-device regions, 46 out of 555,605 donations collected on trima confirmed positive bacterial cultures.The customer declined to provide additional information for the investigation such as procedural details, lot information, patient information, and patient outcome of the 121 confirmed positive bacterial cultures.The disposable sets are not available for return because it was discarded by the customer.

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.Root cause: sources of bacterial contamination include but are not limited to:1.Improper venipuncture technique introduces bacteria at access site resulting in bacterial grow thin product bag.2.Operator does not completely fill bact reservoir resulting in false negative platelet sample which could lead to transfusion of undetected contaminated platelet product.3.Inappropriate materials selected for bact sampler causing bacteria in sampler to be captured or killed resulting in false negative platelet product samples.

Manufacturer Narrative

Additional investigation: per internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

• 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: 6938731
• MDR Text Key: 90312104
• Report Number: 1722028-2017-00396
• 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?: No
• Is this a Product Problem Report?: Yes
• 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