EZ-Flow 480 Infusion Pump 1058 units – Death

9/30/97 EZ-Flow 480 Ambulatory Infusion Pump

1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.

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