The customer reported a stem cell collection was not sterile and the patient required prophylactic antibiotic treatment due to the contamination.Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run files.The disposable kit is not available for return, because it was discarded by the customer.
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Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer reported that the culture was positive for propionibacterium acnes.Per literature review, propioni bacterium acnes is a gram positive skin bacteria that is involved in acne.During investigation of other reported events, it was found that they currently have a 20% bacterial contamination rate of their apheresis products (typically the contamination rate for autologous products is around 0-4%).This was also discussed at length, and is most likely due to improper use of the central lines.Per internal documentation, the phenomenon of bacterial contamination in blood products is known to occur.Given the nature of microorganisms on human skin and the mechanical act of piercing the skin, it is not possible to completely eliminate bacterial contamination from occurring.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 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: no system-related root cause for the alleged bacterial contamination was identified in the run data file for this procedure.No alarms, procedure pauses, or centrifuge stops occurred during the procedure.Review of the images shows no abnormal behavior or foreign matter in the connector and signals in the run data file indicate the set was loaded and primed within the one-working shift upon recomm provided in the spectra optia essentials guide.Additionally, the sterility assurance system employ at terumo bct ensures the device is not the source of contamination.Sources of bacterial contamination include but are not limited to patient connection to the disposab (venipuncture), post-processing laboratory practices and handling, and/or storage procedures.Literature review:http://www.Ncbi.Nlm.Nih.Gov/books/nbk83685/.
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