Day

September 30, 1997
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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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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