Fresenius Kabi

Failed Impurities/Degradations Specifications

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Emphasizing instructions for LVP duration programming located in the IFU.

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.