Sam Brusco, Associate Editor01.15.24
The U.S. Food and Drug Administration (FDA) has identified Fresenius Kabi USA’s November 29 recall of its Ivenix large volume pump (LVP) as Class I.
Fresenius Kabi recalled the pump because some units have mechanical issues with the fluid valve pins inside the pump’s internal housing that cause the pins to move improperly. Instead of going to the correct location, they impact the side of the sensor.
When this happens, the system detects the failure and sounds an alarm, stopping the infusion if it’s in progress and preventing the pump from working. The failure can also be detected during the LVP setup, causing a delay in beginning treatment.
Using the affected product may lead to underdose, therapy interruption, or therapy delay. Fresenius has not yet reported any injuries or deaths related to the issue.
The Ivenix LVP is one of three primary components of the Ivenix infusion system. It's a pump that uses air pressure to precisely control flow of fluids to the patient.
The Ivenix infusion system is used in hospitals and outpatient centers to carefully give fluids to patients, through different routes like IVs, in arteries, in the spine, or under the skin. It is intended for adults, pediatrics, and newborn babies.
Customers were urged to increase clinical monitoring if life-sustaining medications are being delivered using the pump. Different pumps should be used if the LVP shows a Pump Problem alarm during setup, and removed should the LVP exhibit a Pump Problem alarm during use.
The company said it will contact customers to create a plan to address any affected LVPs beginning this month.
Fresenius Kabi recalled the pump because some units have mechanical issues with the fluid valve pins inside the pump’s internal housing that cause the pins to move improperly. Instead of going to the correct location, they impact the side of the sensor.
When this happens, the system detects the failure and sounds an alarm, stopping the infusion if it’s in progress and preventing the pump from working. The failure can also be detected during the LVP setup, causing a delay in beginning treatment.
Using the affected product may lead to underdose, therapy interruption, or therapy delay. Fresenius has not yet reported any injuries or deaths related to the issue.
The Ivenix LVP is one of three primary components of the Ivenix infusion system. It's a pump that uses air pressure to precisely control flow of fluids to the patient.
The Ivenix infusion system is used in hospitals and outpatient centers to carefully give fluids to patients, through different routes like IVs, in arteries, in the spine, or under the skin. It is intended for adults, pediatrics, and newborn babies.
Customers were urged to increase clinical monitoring if life-sustaining medications are being delivered using the pump. Different pumps should be used if the LVP shows a Pump Problem alarm during setup, and removed should the LVP exhibit a Pump Problem alarm during use.
The company said it will contact customers to create a plan to address any affected LVPs beginning this month.