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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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 reported dark spots or blotches on the customers tubing was determined to be the result of (b)(6) medical center's contaminated water system.A sample of the spotted tubing, from one of the customers devices, was sent to cardioquip from (b)(6) medical center, for testing.A swab sample was taken of the tubing and found 200 cfu/swab of m.Franklinii.Cardioquip conducted testing at (b)(6) 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 device also tested positive for m.Franklinii.
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