# K042121: Spectrum and Spectrum with Master Drug Library

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Intl.
- Decided: Aug 26, 2004 after 20 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 18 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904518 (1990). 7 ancestors in all.
28 later devices descend from it; 3 cite it directly.
10 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 2.
- K011975: Horizon Outlook with Dosecom, B.Braun Medical, Inc. (2001) Summary page 2.
- K950766: Sigma 8000 and Sigma 8002, Sigma Intl. General Medical Apparatus, Inc. (1995) Summary page 3.
- K002211: Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151, Baxter Healthcare Corp (2000) Summary page 3.

## Most influential descendants
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (2014), 18 descendants of its own
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), 9 descendants of its own
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K142374: ivWatch Model 400 (2015), 5 descendants of its own
- K153605: ivWatch Model 400 (2016), 4 descendants of its own

## Recalls of this device
- Jan 6, 2021 · Class II · Z-1150-2021: Battery performance issues related to prolonged storage.
- Nov 23, 2020 · Class II · Z-0713-2021: There is a potential software error during programming.
- Nov 23, 2020 · Class II · Z-0712-2021: There is a potential software error during programming.
- Jun 30, 2020 · Class I · Z-0120-2021: Baxter is updating the device IFU for safety communication regarding cleaning practices.
- May 8, 2018 · Class II · Z-2112-2018: 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
- Apr 3, 2018 · Class II · Z-1667-2018: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests 
- Apr 3, 2018 · Class II · Z-1664-2018: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests 
- Apr 3, 2018 · Class II · Z-1666-2018: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests 
- Apr 3, 2018 · Class II · Z-1665-2018: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests 
- Apr 3, 2018 · Class II · Z-1663-2018: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests 
- Sep 28, 2016 · Class II · Z-0670-2017: 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 3, 2014 · Class II · Z-2738-2014: One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
- Feb 7, 2014 · Class I · Z-1484-2014: Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
- Sep 24, 2013 · Class II · Z-0189-2014: Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.
- Jun 10, 2013 · Class II · Z-0197-2014: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms o
- Apr 23, 2012 · Class III · Z-2030-2012: Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represe
- Jul 6, 2011 · Class I · Z-1490-2012: Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. 
- Sep 15, 2010 · Not classified · Z-0146-2011: The infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion.

## Indications for use
The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.

Source page: https://510kreport.com/device/K042121
Methodology: https://510kreport.com/methodology