Medical device manufacturer, Baxter Healthcare has issued a medical device safety alert concerning Colleague Single Channel CXE Pump, V1.7 with item code 2M91617 and serial number 21010369DL.
According to the safety alert, the issue is related to the use of an incorrect User Interface Module (UIM) during service.
The use of the incorrect spare part could lead to a pump shutdown without an alarm (Silent shutdown) if the UIM Printed Circuit Board Assembly fails. This defect could occur before starting or during therapy that could potentially cause a delay of infusion or interruption of infusion.
According to the local supplier, the affected products are distributed in Hong Kong.
The manufacturer will collect the affected device for correction.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 May 2015