Infusion Pumps

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

The door on the Spectrum IQ Infusion pump may not be able to fully close.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

A limited number of IV bags have been found to leak during filling.

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

A limited number of IV bags have been found to leak during filling.

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.