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Infusion Safety Management Software
FDA product code PHC · Class 2 · General Hospital
46
Registered devices
88
Adverse events
13
Recalls
10
510(k) clearances
Devices with this code
BD Intelliport — BECTON, DICKINSON AND COMPANYCommonPath Enterprise — Critical AlertBD Intelliport System — BECTON, DICKINSON AND COMPANYIvenix Infusion System — Fresenius Kabi AGBD Alaris™ Calculation Services, Software — CAREFUSION 303, INC.Spectrum IQ — BAXTER HEALTHCARE CORPORATIONBD Intelliport — BECTON, DICKINSON AND COMPANYIvenix, Inc. — Fresenius Kabi AGLifeShield Infusion Safety Software Suite - LifeShield DLM — ICU MEDICAL, INC.Ivenix Infusion System — Fresenius Kabi AGICU Medical MedNet — ICU MEDICAL, INC.BD Alaris™ System Manager 9601, Software — CAREFUSION 303, INC.Ivenix Infusion System — Fresenius Kabi AGSIGMA Spectrum Infusion Pump — BAXTER HEALTHCARE CORPORATIONLifeShield Infusion Safety Software Suite — ICU Medical, Inc.Alaris — CAREFUSION 303, INC.PharmGuard — ICU MEDICAL, INC.Vigilant Software Suite — Fresenius Kabi AGIvenix Infusion System — Fresenius Kabi AGBD Intelliport — BECTON, DICKINSON AND COMPANYBD Intelliport System — BECTON, DICKINSON AND COMPANYAlaris — CAREFUSION 303, INC.PharmGuard — ICU MEDICAL, INC.BD Intelliport System — BECTON, DICKINSON AND COMPANY
Recent 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 use |
| 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 mus |
| 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 wi |
| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).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| 2025-02-18 | CareFusion 303, Inc. | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).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 secondar |
| 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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