The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The spotted tubing is a result from lankenau medical center's contaminated water system.The spotted tubing was sent to cardioquip from lankenau medical center, for testing.A swab sample was taken of the tubing and found 200 cfu/swab of m.Franklinii.Cardioquip conducted testing at lankenau medical center and sampled various devices, source water, ice machine, and coolers.The lab reports indicated the same mycobacterium, m.Franklinii, was also found to be a contaminant within their source water, in which they used to fill up their heater-coolers.The spotted tubing was used on device serial number (b)(4) and that device also tested positive for m.Franklinii.
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Customer reports that the antimicrobial tubing of their heater coolers has developed dark spots or blotches, and they are very confused as to why this is occurring.The customer says they use bleach as a primary disinfectant, perform cleanings at least quarterly and that their facility uses water which has passed through a 0.2 micron filter.
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