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

Catalog Number 80440

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/20/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the journal article, bacterial detection testing of the collected from bsi was performed at ubs centers utilizing identical protocols for trima devices throughout the study period.Apheresis platelet sampling from the mother bag was performed at 24 to 36 hours after collection.Study period a was performed in november 24, 2008 to august 25, 2012 and 188,389 trima collection with a 5-day shelf life were tested for bacterial contamination using a sample of approximately 9 ml into one aerobic culture bottle.Results indicated 17 true positive for bacterial contamination.Study period b was performed in august 26, 2012 to february 24, 2014 and 74,383 trima apheresis platelet units with a 5-day shelf life that were tested for bacterial contamination using a sample of approximately 9 ml for collections yielding a single plt component in one aerobic culture bottle or approximately 19ml for collections yielding double and triple components into two aerobic culture bottles with 9to 10 ml in each.Results indicated 9 true positive for bacterial contamination.Inoculated bottles were loaded into the bacterial testing system (bact/alert 3d) within 1 hour of inoculation and incubated at 3661 degree celsius for 5 days or until a positive result was obtained.After 24 hours (september 2003-july 2009), 18 hours (july 2009-january2011), and 12 hours (since january 2011) hours of incubation, plts associated with an aerobic culture bottle that had not triggered a positive signal on the bacterial testing system were released.Culture bottles that generated a positive signal and available associated plt units were sent, within 24 hours, to a single clia-accredited reference microbiology laboratory for confirmatory testing (gram stain and culture, including organism identification).Any bottle that became positive after 12 hours resulted in the associated product being recalled, and if released and/or transfused, the hospital was notified.Bacterial detection testing at nybc also used the bacterial testing system (bact/alert 3d)following a uniform protocol for trima devices throughout the study period.Apheresis platelet sampling from the mother bag was performed at 24 to 30 hours after collection.Apheresis platelet units had a 5-day shelf life and were tested for bacterial contamination using an 8-ml sample into one aerobic culture bottle.The inoculated bottles were loaded into the bacterial testing system within 1 hour of inoculation and incubated at 3661_c for 5 days or until a positive result was obtained.If culture bottles generated a positive signal, a new sample was obtained from the available plt unit.A new set of bpa bottles for all plt products was inoculated and, if negative, the original was considered a false positive (fp).If positive, bottles were sent to a clia accredited reference microbiology laboratory for culture and identification.If the product had already been transfused, the second inoculation step was skipped and the original bpa bottle was sent for culture and identification.After 16 hours of incubation, all plts associated with a negative-to-date bottle were released.Any bottle that became positive after that time resulted in the associated product being recalled and if released and/or transfused, the hospital facility was notified.Pre-collection and disinfection and in-line diversion sets were utilized for trima devices throughout the study period at bsi sites.Leukoreduction apheresis platelets were collected from the nybc site utilizing pre-collection arm disinfection and in-line diversion sets for trima throughout the study period of january2010 to december 2013.For both bsi and nybc, the final classification of plt units with positive signals was based on bacterial confirmatory testing of the aerobic culture bottles and ap components.Nybc follows the aabb recommendations for classification.Bsi used modified aabb recommendations, which include final classification of discordant negative (dn) results.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., &townsend, m.(2015).Detection of bacterial contamination in apheresis platelets: is apheresistechnology 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 blood systems, inc.(bsi) and the new york blood center (nybc) collected apheresis platelets using trima collection devices for a retrospective study; 262,772 platelet collections were collected at bsi from the study period of november 2008 to february 2014.Bacterial testing were performed on the collected apheresis units from bsi.Test results indicated 26 true positive and 5 indeterminate results for bacterial contamination.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

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:- improper venipuncture technique introducing bacteria at access site resulting in bacterial grow thin product bag.- operator does not completely fill bact reservoir resulting in false negative platelet sample which could lead to transfusion of undetected contaminated platelet product.- inappropriate materials selected for bact sampler causing bacteria in sampler to be captured orkilled 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: 6950104
• MDR Text Key: 90647174
• Report Number: 1722028-2017-00401
• 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?: 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: 09/21/2017
• 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