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Ivenix Infusion System
Fresenius Kabi AG · Model 030-0027-05 · UDI-DI 00811505030399
PHC
Prescription
1
510(k) clearances
88
Adverse events
13
Recalls
24
Facilities
Description
Infusion Management System (IMS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-24 | ICU Medical, Inc. | Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use C |
| 2025-11-24 | ICU Medical, Inc. | For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate meth |
| 2025-06-20 | Baxter Healthcare Corporation | Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-06-20 | Baxter Healthcare Corporation | Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-05-02 | ICU Medical, Inc. | Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, p |
| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2022-09-08 | Fresenius Kabi USA, LLC | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. Howe |
| 2022-04-22 | Ivenix, Inc. | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |
| 2020-08-04 | CareFusion 303, Inc. | Infusion pump component defect may result in interruption of patient monitoring |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.