The customer reported a positive bacterial culture on a washed red blood cell (rbc) product.The organism identified was bacillus species, not anthracis and curtibacterium acnes.The product was washed on (b)(6) 2020 and sent for gram stain and culture.The initial gram stain was "no organisms seen" on (b)(6) 2020, the culture of washed rbc unit first tested positive for gram positive rod.Unit id: (b)(6).It is unknown at this time if the product was transfused to a patient.The disposable set is not available for return because it was discarded by the customer.
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This report is being filed to provide corrected information in a.1, and additional information in b.5, e.3, h.6, and h.10 investigation: a disposable history search indicated there were no other reported occurrences of microbial contamination on this lot worldwide.The customer reported that the culture was positive for bacillus spp and cutibacterium acnes.Per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Cutibacterium acnes is a bacterium associated with skin infections.It is a gram-positive, non-spore forming, and anaerobic bacillus.C.Acnes mainly colonizes hair follicles of the upper body, including the head, neck, shoulders, and axilla.It predominantly resides on the skin and in the sebaceous glands associated with hair follicles.Cutibacterium acnes is the primary cause of shoulder surgery infections.Per internal laboratory 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 assurance system employed at terumo bct ensures the disposable device is not the source of contamination.Root cause: a definitive root cause could not be determined.Sources of bacterial contamination include but are not limited to connection to the disposable set, third party solutions used in the procedure and/or post-processing laboratory practices such as qc sampling or handling techniques.Additionally, the sterility assurance system employed at terumo bct ensures the device is not the source of contamination.
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