User facility personnel were not preparing the dsd 201 aer properly prior to the start of a cycle subsequently causing the reported event to occur.The reservoirs inside the unit's cabinet that houses the chemistry for each side of the unit have a heater on them that should be set between 38-40c.The user facility had their reservoirs set at 34c.There are temperature sensors on both sides of the unit that were set at 30c, but should have been set to 36c.The technician also observed that the temperature sensors were disabled.The user facility's biomedical technician had disabled the sensors due to a reoccurring alarm.The reoccurring alarm was due to the temperature sensors not being within the required settings.The technician was able to review cycle printouts which confirmed that the temperatures were too low to meet the minimum temperature requirements on the rapicide glutaraldehyde labeling.The dsd 201 aer is manually programed so if the user does not set up the programming correctly and ineffective cycle will occur.During the in-service training it was also observed that user facility personnel were using modified hook-ups.User facility personnel were modifying the hook-ups by utilizing olympus cleaning adaptor tubing and putting medivators basin connectors on the end of it.Prior to reprocessing, users must verify that the hookup used contains connections for all appropriate channels that require a separate reprocessing connection according to the hookup instructions.Medivators makes no claim on high-level disinfection efficacy when these reprocessing instructions are not followed, or when this hookup kits are used other than those specified in the hookup guide.Medivators is not aware of any adverse clinical event associated with this incident and is filing this mdr because the high-level disinfection of devices processed in the dsd-201 endoscope reprocessing system cannot be guaranteed unless devices are processed in accordance with medivators instructions for processing and use.Steris technician completed his in-service training on the proper use and operation of the dsd 201 aer and returned the unit to service.No additional issues have been reported.
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