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=10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every lot of product manufactured.The sterility ¿assuance¿ system employed at terumo bct ensures the disposable device is not the source of contamination.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.Citation: carl mcdonald, jennifer allen, susan brailsford, anjana roy, joanne ball, richard moule, marizavasconcelos, rachael morrison, and tyrone pitt (2017).Bacterial screening of platelet components by national health service blood and transplant, an effective risk reduction measure.Transfusion, 57: 1122-1131.Doi: 10.1111/trf.14085.
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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.Per the article this apheresis plt donation (unit age 5 days) was culture-negative on screening and was classed as a near miss after health care staff noted visible clumping of material in the packs before transfusion.S.Aureus was implicated.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 set is not available for return.
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