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Cardinal Health, owner of Alaris® Products, is informing you of a potential for over infusion with all models of the Alaris® SE Pumps (formerly the Signature Edition® Infusion Pumps) caused by key bounce. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times(10X) the intended infusion rate. Key bounce occurs when a number registers twice although the operator only pressed the key once. For example, if an infusion rate is intended to be entered as 4.8 mL/hr and the key bounce occurs when the 4 is pressed the actual rate registered will 44.8 mL/hr.
If not detected during programming verification, key bounce events may result in serious patient harm or death. You must check all programming parameters before starting any infusion therapy.
Cardinal Health will be sending you "Warning Labels" which must be placed on each device. These labels are intended to visibly reinforce the critical requirement of verifying programming accuracy prior to initiating infusion. (These labels will be sent to the Director of Biomed and Director of Nursing for each facility). They read as follows:
WARNING: Key bounce malfunction may cause data entry errors. It is critical to verify all programming parameters on the display screen prior to initiating RUN/HOLD during basic setup and following any changes to programming. Verify that flow in drip chamber appears appropriate for expected infusion rate.
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