Lab results((b)(6) 2024): 10160231 - 2760 mpn/ml (above acceptable limit).To remediate the device contamination, the customer can consider reperforming cleaning and disinfection procedures located on pg.55 - 59 of the mch-1000 operator/service manual.If cleaning and disinfection is unable to return hpc test results to acceptable limits and unable to remove visual signs of contamination, cardioquip recommends the return of the device back to our facility for further investigation.
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A cardioquip technician submitted photos of tubing to epidemiology for investigation during an on-site inspection.Due to the discoloration of the tubing, epidemiology recommended that the device receive hpc testing to provide a quantitative assessment of water quality.Following test results outside of cardioquip specifications, cardioquip recommended that either, (1) the customer reperform cleaning and disinfection procedures detailed in the ifu and reperform hpc testing, (2) have the device receive an internal water pathway replacement or, (3) participate in cardioquip's trade in program.These options would return the device to specification and full functionality.These options were relayed to the customer via email.As of the date of this report the customer has not responded to these options.
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