# K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: May 7, 2014 after 145 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 15 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904518 (1990). 8 ancestors in all.
18 later devices descend from it; 3 cite it directly.
9 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042121: Spectrum and Spectrum with Master Drug Library, Sigma Intl. (2004) Summary page 1.

## Most influential descendants
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), 9 descendants of its own
- K142374: ivWatch Model 400 (2015), 5 descendants of its own
- K153605: ivWatch Model 400 (2016), 4 descendants of its own
- K220417: Spectrum IQ Infusion System with Dose IQ Safety Software (2022), 3 descendants of its own
- K162478: ivWatch (2016), 3 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class I · Z-2095-2025: Certain Spectrum infusion pumps may have an incorrect version of software.
- Feb 5, 2025 · Class I · Z-1253-2025: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Nov 19, 2024 · Class II · Z-0775-2025: Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Dec 29, 2021 · Class I · Z-0530-2022: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomp
- Jan 6, 2021 · Class II · Z-1150-2021: Battery performance issues related to prolonged storage.
- Nov 23, 2020 · Class II · Z-0714-2021: There is a potential software error during programming.
- Jun 30, 2020 · Class I · Z-0121-2021: Baxter is updating the device IFU for safety communication regarding cleaning practices.
- Jun 30, 2020 · Class I · Z-0122-2021: Baxter is updating the device IFU for safety communication regarding cleaning practices.
- Jun 21, 2018 · Class II · Z-1248-2019: The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly 
- May 8, 2018 · Class II · Z-2113-2018: The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary in
- Oct 6, 2017 · Class II · Z-0971-2018: Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
- Jan 26, 2017 · Class II · Z-1693-2017: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the err
- Sep 28, 2016 · Class II · Z-0671-2017: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increa
- Sep 28, 2016 · Class II · Z-0672-2017: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assembl
- Mar 2, 2015 · Class II · Z-1451-2015: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minute

## Indications for use
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas. The Daxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K133801
Methodology: https://510kreport.com/methodology