Ivenix infusion pumps may hide internal damage after being dropped
Ivenix Infusion System Large Volume Pumps are being recalled because dropping or jarring can loosen the touchscreen input cable, causing random touches or an unresponsive screen.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Ivenix Infusion System (IIS) Large Volume Pump, model number LVP-0004, UDI-DI 00811505030320, is being recalled across all serial and lot numbers. The action covers 18,444 units.
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible, so affected devices remained in service. Specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behaviour including random screen touches and/or a lack of screen responsiveness to user input. Unintended touch inputs may register at arbitrary screen locations without user interaction, intermittently and without a predictable pattern. The FDA classified the action as Class I, its most serious classification.
Distribution was domestic, across a large number of states. The pumps are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the model number and UDI-DI above and follow the instructions issued by Fresenius Kabi, including any guidance on inspecting pumps that have been dropped.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 18,444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: LVP-0004
- UDI-DI: 00811505030320
- All Serial/Lot Numbers:
Distribution
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