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 customer suspected that a few devices have biofilm growth in the internal tubing.Cardioquip recommended an internal water path replacement.The device was sent in for internal water path replacement and tested prior and post replacement.The cfu count was within the acceptable level post replacement.
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