Getinge Disinfection AB, CAPA 627769, Getinge ED-FLOW Range

Getinge has discovered that a temperature sensor in the ED-FLOW AER chamber may not work as intended and may provide incorrect temperature readings for washing and disinfection temperature during process. The result on the process ticket has shown OK despite the temperature not having reached the parameters required for validated biocidal activity.
The ED-Flow chamber is equipped with two temperature sensors, the Controlling value (CTRL) and the Independent Value (I.V.). These sensors values are shown on the process ticket.
The difference between the Controlling value (CTRL) and the Independent value (I.V) must not differ more than 2°C.
The machine does not give an alarm if the temperature differ between CTRL and I.V. The machine only alarms when the Controlling value (CTRL) temperature is too low or too high. It does not alarm if only the Independent value (I.V.) temperature is too low or too high.
The printed ticket displays “OK” even when there is a greater difference in washing or disinfection temperature than allowed.
If a larger difference than 2°C occur, the temperature sensors (CTRL and I.V.) need to be recalibrated and the endoscopes reprocessed.