On 3rd june, 2019 getinge became aware about an issue with one of the steam sterilizer- 533hc model number.As it was stated, there was an excessive steam in the device chamber that leaked into the root when the operator opened the device door.There was no injury reported, however, taking under consideration the worse case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.
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Information in section d4 regarding serial# was corrected from (b)(6) to (b)(6).On 3rd june, 2019 getinge became aware about an issue with one of our steam sterilizer- model number: 533hc.As it was stated in the received information, there was an excessive steam in the device chamber that leaked into the room when the operator opened the device door.There was no injury reported, however, taking under consideration the worst case scenario that any unexpected steam leak from parts available to the customer might lead to an adverse event, it was decided to report this issue based on the potential.When reviewing reportable events, we were able to establish that there is no apparent trend for complaints of this type.After issue occurrence, the device was inspected by getinge technician.It was stated that the fast exhaust check valve was heavily soiled and not freely moving.Moreover, the ejector had some sediment built up and was cleaned.The steam to chamber valve was inspected and found be operational.After action taken the device passed two bowie-dick tests and was returned for customer usage.The product involved in the incident is the 533hc steam sterilizer with the serial number: (b)(6).The unit was manufactured 20th march 2014 on and installed on 24th april, 2014.The dhr was reviewed and no anomaly was found.It was established that the device is under getinge preventive maintenance (pm).Prior to the incident the pm was performed by getinge representative on 13th march, 2019.The issue was discussed with subject matter expert (sme).As described by service technician, components (valves, check valves and ejector) were heavily soiled by mineral deposits, therefore it was established as most probable that poor quality of facility media contributed to the event.The information regarding water quality and how it might affect on the steam sterilizer are provided to user in the instructions for use (ifu) for this device.This as well as device maintenance is under customer responsibility.Based on the service and pm history of the device it cannot be established if the quality of the facility media was checked.According to user manual (doc.(b)(4) the interval at which the steam boiler is to be blown down depends upon the quality of water supply.Based on the device pm history, the manual blowdowns of the boiler mounted on the device was performed on 14th december, 2018.However, from pm performed after the issue on 4th june it was noted that the liquid level probes and pressure control lines in boiler were also cleaned.In summary, when the event occurred, the device did not meet its specification and it contributed to the event.In the time when the event occurred, the device was not being used for patient treatment.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.
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