Medical device manufacturer, SenTec AG, has issued a medical device safety alert concerning its Membrane Changers and their Inserts. The affected products are identified as following:
Due to a manufacturing issue of the electrolyte cartridge of certain Membrane Changer (MC) Inserts, there is an increased chance (approximate 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure if a Membrane Changer with such an Insert is used.
In case of no electrolyte, the membrane appears with whitish areas/spots upon completion of the membrane change procedure. In such a case, another membrane change procedure shall be performed. The PCO2 performance of a sensor without electrolyte will be deteriorated. During subsequent use, built-in sensor diagnostics in most cases will trigger appropriate alarms/messages and replace PCO2 readings by "---" or mark them to be unstable or questionable.
According to the manufacturer, a reduced amount of electrolyte may result in trapped air under the membrane upon completion of the membrane change procedure. This is an indication for a membrane change, according to the Directions for Use (HB-005147-k and HB-007415-c), and another membrane change procedure shall be performed. However, a membrane change procedure with a reduced amount of electrolyte may also result in a normal appearing sensor. The reduced amount of applied electrolyte can result in a reduced lifetime of the membrane due to dried out electrolyte or the occurrence of trapped air under the membrane. During subsequent use, the sensor may function correctly, or show an increased drift in the PCO2 readings.
Users are advised to take the following actions:
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 May 2019