Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

FDA device recall Z-1313-2023 · posted 2023-04-18 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

Action taken

The firm distributed via email a URGENT - Medical Device Recall notification to consignees identifying all large volume pumps (LVP) of the Ivenix Infusion System as requiring repair or replacement due to potential fluid ingress, which could lead to interrupted infusion of medication. Customers are instructed to have a secondary LVP readily available when the device is being used to deliver life-sustaining medication if the provided troubleshooting instructions do not resolve the cessation of infusion. Additionally, customers are to ensure no buildup of liquid on the Air Detector region surfaces by wiping away any fluid buildup and reloading the cassette if the LVP exhibits an alert. Additional instructions were provided based upon varying clinical situations and should be posted above each nursing station where the device is in use. Fresenius will be contacting their customers to arrange service in response to this recall event. Adverse events or quality problems should be reported to Fresenius at Ivenix_support@fresenius-kabi.com. Customers are asked to return the Customer Reply Form provided with the recall notification and to forward the recall notice to any customers/satellite locations at which recalled devices were further distributed.

Root cause

Process control

Status

Open, Classified

Product code

FRN

Quantity affected

1,546 units

Distribution

Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.

Date initiated

2023-03-10

Date posted

2023-04-18

Location

North Andover, MA

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