On (b)(6) 2017 arjohuntleigh has been informed by customer (b)(6) that based on the results of microbiological tests, (b)(6) department ceased further usage of the system 2000 bath (serial number (b)(4)) due to excessive levels of pseudomonas aeruginosa bacteria and aerobic colony count.No adverse event or injury was reported.The review of similar reportable events with the involvement of the system 2000 baths in last 5 years, revealed a low number of cases where it was indicated that the bath was contaminated with the pseudomonas aeruginosa bacteria.The occurrence rate observed for this failure mode is considered to be low.Please note that pseudomonas aeruginosa is a common environmental organism and can be found in faeces, soil, water and sewage.It can multiply in water environments and also on the surface of suitable organic materials in contact with water.It can be spread by equipment that gets contaminated and is not properly cleaned and maintained.On 2017-jul-07 the arjohuntleigh representative visited the (b)(6) facility to inspect the claimed bathtub.The arjohuntleigh representative found that the water pressure during the disinfectant stage was too low.It was suggested to the customer to increase the water pressure during disinfection of the bathtub.After implementation of changes leading to the water pressure increase, on 2017-sep-20 next swabs were taken to verify if bacteria presence was reduced to an acceptable level.Based on the ehs officer report an unsatisfactory pseudomonas aeruginosa count is >10 per 100ml and an unsatisfactory aerobic colony count is >10 per 100ml.The test results confirmed that bacterium level was reduced below the level established by ehs and are therefore satisfactory.Next samples were taken on 2017-oct-04 and results were acceptable as well.In summary, the complaint was decided to be reportable based on the allegation that arjohuntleigh bath system 2000 is contaminated with bacteria.During the investigation it became evident that bath system was not source of the pseudomonas aeruginosa bacterium - increase of water pressure in disinfection stage eliminated the bacteria and resolved the issue.The results of the investigation performed enable us to determine that allegation reported does not compromise patient safety and is not likely to cause or contribute to a death, serious injury or deterioration in state of health.Therefore this type of event will no longer be seen as reportable complaint.
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