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

Catalog Number 80440

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available per the customer.Per follow-up, the catalog used for these ¿event¿ was not provided; therefore, 80440 will be used.Investigation: during follow-up with the author of the journal article, it was determined that no additional information or individual patient/donor information will be provided to terumo bct.The author declined to provide further details concerning these events, and therefore, per section 4.16.2 of the medical device reporting for manufacturers: guidance for industry and drug administration station document issues july 9, 2013 one mdr will be submitted for each identified device and failure mode.Per the author of the article terumo bct devices are not being suspected of contributing to the bacterial contamination, patient reactions or deaths.The terumo bct products were used solely as a means of collecting product for the study.The nhsbt in (b)(6) introduced diversion nationally in 2003 and improved arm disinfection in 2007.In 2011, nhsbt introduced screening of all platelet components for bacteria as a further risk reduction measure.The article represents the first 4 years and 7 months (february 2011 to september 2015) of the screening program using an automated microbial detection system.The article concluded that 'implementation of bacterial screening of plt components with the nhsbt bact/ alert protocol was an effective risk reduction measure and increased the safety of the blood supply¿.All sampled plt products meet the study specification of 2.4x10^11 or greater and the white blood count (wbc) in each product was below 5x10^6.Results per the article: according to mcdonald et al, from 'february 2011 to september 2015, a total of 1,239,029 plt components were screened.Initial-reactive, confirmed-positive, and false-positive rates were 0.37, 0.03, and 0.19%, respectively.False- negative cultures, all with staphylococcus aureus, occurred on four occasions; three were visually detected before transfusion and one confirmed transmission resulted in patient morbidity.The nhsbt screening protocol effectively reduced the number of clinically adverse transfusion transmissions by 90% in this reporting period, compared to a similar time period before implementation.Delayed testing of 4515 time- expired plt units after screening revealed no positives.Prior to inoculation, the protocol at the customer site was, while the operator wore non-sterile gloves, to wipe the septum of the bottle with an alcohol wipe.The components were held for 36-48 hours post collection, a 16ml sample was taken from the sampling pouch that was attached using the tscd ii device.All units were treated the same apart from pediatric units which were pooled together.All negative results were added the nhsbt computer system.Positive initial reactive results from the bact/alert system resulted in a hold or recall of the product.Additional investigation was made on the units that were already undertaken at a facility.It was determined that the source of the contamination based on the species distribution, was skin flora.Per the article, "at the beginning of the screening process, the plt products were manufactured at a ratio of 80% apheresis to 20% of pooled units (buffy coat derived from four donations), moving to 60% apheresis and 40% pooled units in 2015.Initially, all plt products were suspended in 100% plasma, but from february 2015, the use of plt additive solution (pas; ssp1, macopharma) for pooled units was phased in and all manufacturing centers produced pooled plts suspended in 65%:35% (pas: plasma) as of july 2015.All reported mother bags were split into therapeutic doses at 3 to 4 hours post collection.Buffy coat¿pooled plts were prepared from four donations.""among confirmed positive pooled plt components in which all components (including associated rbc units) were returned for testing, 58.2% were positive in the index unit alone and 33.7% in both index and rbc units.In all cases, bacteria were detected in only one of the four rbc units under test.For pooled plt components where the index plt unit was not available for testing, 78 (40.2%) incidents of bacterial contamination were confirmed by testing of the rbc units alone."per internal sterilization documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

During a terumo bct review of the transfusion journal, ¿bacterial screening of platelet components by national health service blood and transplant, an effective risk reduction measure.¿ researchers: carl mcdonald, jennifer allen, susan brailsford, anjana roy, joanne ball,richard moule, mariza vasconcelos, rachael morrison, and tyrone pitt performed bacterial screening on platelet (plt) components in five regional national health service blood and transplant (nhsbt) sites.The sites were: bristol, manchester, sheffield, newcastle, and london.All 250,000 apheresis plt products were collected on the trima system.Per the article, there were five cases in which possible medical intervention or serious injury could have occurred as the platelet (plt) units were rejected for transfusion by visual inspection due to the presence of "clumps" in the component.Four grew staphylococcus aureus and oneraoutella planticola (formerly klebsiella spp.).In a comparable period and a similar number of screened units, nhsbt recorded a single confirmed reported bacterial transmission resulting in morbidity, three near misses, and no deaths.Due to eu personal data protection laws, the patient information is not available from the customer.The author of journal article declined to provide procedural details, patient information, and patient outcome/factors.The disposable sets are not available for return.

Manufacturer Narrative

Investigation: per terumo bct's internal risk evaluation documentation and the information provided in this publication, there is no evidence to indicate that the trima system including the tscd ii sterile connection device caused or contributed to the patient's bacterial infection.Per terumo bct medical review process the device did not cause or contribute the potential for injury.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: sources for the bacterial contamination in the products could not be determined.Possible root causes of the bacterial contamination include but are not limited to:- post processing lab qc sampling/handling techniques; leak in disposable set due to manufacturing error; poor phlebotomy venipuncture.

• 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: 8189823
• MDR Text Key: 131172046
• Report Number: 1722028-2018-00352
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 01/31/2019
• Supplement Dates FDA Received: 01/15/2019; 02/04/2019
• 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