Infusion Safety Management Software
FDA product code PHC · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
10510(k) clearances
0PMA approvals
13recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2026SE |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | Becton Dickinson | 06/20/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 03/29/2024SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 08/24/2023SE |
| K211124 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 08/30/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | Fresenius Kabi AG | 03/01/2022SE |
| K182092 | BD Intelliport SystemPHC · Traditional | Becton, Dickinson and Company | 04/30/2019SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | Becton, Dickinson & CO | 12/18/2014SE |
| K141193 | Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0PHC · Traditional | Smiths Medical Asd, Inc. | 07/25/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0966-2026 Class II | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2…Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal… | ICU Medical, Inc. | 11/24/2025Open, Classified |
| Z-0965-2026 Class II | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2…For certain customers, the Change Summary review option ceases to operate as expected for any migrated… | ICU Medical, Inc. | 11/24/2025Open, Classified |
| Z-2096-2025 Class I | Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2Certain Spectrum infusion pumps may have an incorrect version of software. | Baxter Healthcare Corporation | 06/20/2025Open, Classified |
| Z-2095-2025 Class I | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXCertain Spectrum infusion pumps may have an incorrect version of software. | Baxter Healthcare Corporation | 06/20/2025Open, Classified |
| Z-1763-2025 Class II | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1…Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to… | ICU Medical, Inc. | 05/02/2025Open, Classified |
| Z-1305-2025 Class I | BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management SoftwareSoftware issue that may result in outdated automated programming request(APR) being sent to the progressive… | CareFusion 303, Inc. | 02/18/2025Open, Classified |
| Z-1304-2025 Class I | BD Alaris Systems Manager , REF 9601 Infusion Safety Management SoftwareSoftware issue that may result in outdated automated programming request(APR) being sent to the progressive… | CareFusion 303, Inc. | 02/18/2025Open, Classified |
| Z-0002-2023 Class I | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced… | Fresenius Kabi USA, LLC | 09/08/2022Terminated |
| Z-1381-2022 Class II | Ivenix Infusion System (IIS)Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | Ivenix, Inc. | 04/22/2022Terminated |
| Z-2935-2020 Class II | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive…Infusion pump component defect may result in interruption of patient monitoring | CareFusion 303, Inc. | 08/04/2020Open, Classified |
| Z-2065-2019 Class I | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage:…The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in… | Fenwal Inc | 06/24/2019Terminated |
| Z-0107-2019 Class II | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug… | Baxter Healthcare Corporation | 09/18/2018Terminated |
| Z-1076-2016 Class II | BD Intelliport Medication Management System Sensor The system is indicated for use by…The sterility of the product cannot be assured. This may result in increased risk of infection. | Becton Dickinson & Company | 12/09/2015Terminated |