Baxter Sigma Spectrum Infusion Pump with Master Drug Library

• • Ongoing Z-2095-2025 FDA Class I ·initiated 20 Jun 2025 ·via K133801, on the same 510(k)

  Certain Spectrum infusion pumps may have an incorrect version of software.

• • Ongoing Z-1253-2025 FDA Class I ·initiated 5 Feb 2025

  There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

• • Ongoing Z-0775-2025 FDA Class II ·initiated 19 Nov 2024

  Devices were identified as released after repair without full testing being performed, which includes flow testing.

• • Ongoing Z-0530-2022 FDA Class I ·initiated 29 Dec 2021

  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 incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

• • Ongoing Z-0714-2021 FDA Class II ·initiated 23 Nov 2020

  There is a potential software error during programming.

• • Terminated Z-1150-2021 FDA Class II ·initiated 6 Jan 2021

  Battery performance issues related to prolonged storage.

• 2 recalls, same reason

  • Terminated Z-0122-2021 FDA Class I ·initiated 30 Jun 2020
  • Terminated Z-0121-2021 FDA Class I ·initiated 30 Jun 2020

  Baxter is updating the device IFU for safety communication regarding cleaning practices.

• • Terminated Z-1248-2019 FDA Class II ·initiated 21 Jun 2018

  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 performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.

• • Terminated Z-2113-2018 FDA Class II ·initiated 8 May 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 infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.

• • Terminated Z-0971-2018 FDA Class II ·initiated 6 Oct 2017

  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.

• • Terminated Z-1693-2017 FDA Class II ·initiated 26 Jan 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 error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.

• • Terminated Z-0672-2017 FDA Class II ·initiated 28 Sep 2016

  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 assemblies that have an increased potential to fail prematurely.

• • Terminated Z-0671-2017 FDA Class II ·initiated 28 Sep 2016

  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 increased potential to fail prematurely.

• • Terminated Z-1451-2015 FDA Class II ·initiated 2 Mar 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 minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K133801 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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