Investigation: bpa culture bottles are used with the bact/alert® microbial detection systems for quality control testing of platelets.Bact/alert bpa culture bottles support the growth of aerobic microorganisms (bacteria and fungi).Bpn culture bottles are used with the bact/alert® microbial detection systems for quality control testing of platelets.Bact/alert bpn culture bottles support the growth of anaerobic and facultative anaerobic microorganisms (bacteria).The 20 ml large volume bact samplers increase the volume of inoculum hence better detection of contaminated units with a low bacterial titer.An increase in positive tests is a possibility with enhanced sensitivity.Multiple attempts were made to obtain additional information including the disposable lot number, machine serial numbers, bacterial strains and status of the recipient who had been transfused with products allegedly contaminated with bacterial.The customer did not respond to any of the requests.(b)(6) had results on the first sample (3/16 positive products), and the customer was waiting on results of the resampling data so the results were inconclusive.The phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.The customer did not provide the disposable lot number.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for the microbial contamination with true positive and indeterminate results.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.* inadequate or no blood diversion performed due to operator error resulting in bacterial contamination of product.Species was endogenous and originated from the donor.Inadequate post-processing laboratory practices such as qc sampling or handling techniques.A root cause assessment was performed for the microbial contamination with false positive results.Based on the available information, their qc lab had contaminated the bottles resulting in false positive.
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