A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Fresenius Kabi is removing Ivenix large-volume pumps (LVP) from where they are used or sold, according to a US Food and Drug Administration (FDA) recall notice. This comes after the company identified a misassembly defect within a specific lot of the Ivenix LVP primary administration set where the drip chamber and luer lock are in reversed positions, potentially leading to clinical complications.
An affected set has the luer lock connected proximally in relation to the cassette and the drip chamber connected distally in relation to the cassette. A properly assembled set has the drip chamber connected proximally in relation to the cassette, and the luer lock connected distally in relation to the cassette.
Use of a misassembled set to administer therapy via the Ivenix LVP may lead to reverse flow, where negative pressure draws fluid from the patient connection (luer lock) and positive pressure forces fluid back toward the source container (drip chamber). The shortened downstream tubing (approximately 24 inches instead of approximately 72 inches) may also prevent proper connection to the patient access site unless extension tubing is used.
The degree of risk to the patient is influenced by factors such as the patient condition, flow rate, location of the luer lock connection, and level of oversight. Risks to patients include unexpected infusate delivery due to reverse flow, as well as delay in delivery of life-saving fluids, medications, and blood products. Harms may range from minor (self-limited blood loss in a stable adult) to catastrophic (exsanguination or hemodynamic compromise in neonates or other high-risk populations). Clinical outcomes can vary from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates and hemodynamically unstable patients.
Affected product:
- LVP primary administration set, dual-inlet, low-sorbing, needle-free port, dual Y-site
- Product Code: SET-0032-01 (individual unit), SET-0032-25 (case)
- Lot: FA25B03126
- Unique Device Identifier: 00811505030214
The FDA issued an early alert communication on Nov 24 regarding this issue and updated it to a Class I recall on Jan 5.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
