Spectrum and Spectrum with Master Drug Library

2 recalls, same reason

• Ongoing Z-0713-2021 FDA Class II ·initiated 23 Nov 2020
• Ongoing Z-0712-2021 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.

• Terminated Z-0120-2021 FDA Class I ·initiated 30 Jun 2020

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

• Terminated Z-2112-2018 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.

5 recalls, same reason

• Terminated Z-1667-2018 FDA Class II ·initiated 3 Apr 2018
• Terminated Z-1665-2018 FDA Class II ·initiated 3 Apr 2018
• Terminated Z-1664-2018 FDA Class II ·initiated 3 Apr 2018
• Terminated Z-1666-2018 FDA Class II ·initiated 3 Apr 2018
• Terminated Z-1663-2018 FDA Class II ·initiated 3 Apr 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 include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.

• Terminated Z-0670-2017 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-2738-2014 FDA Class II ·initiated 3 Sep 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.

• Terminated Z-1484-2014 FDA Class I ·initiated 7 Feb 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.

• Terminated Z-0189-2014 FDA Class II ·initiated 24 Sep 2013

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.

• Terminated Z-0197-2014 FDA Class II ·initiated 10 Jun 2013

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 occurring during infusions.

• Terminated Z-2030-2012 FDA Class III ·initiated 23 Apr 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 represent common clinical practices.

• Terminated Z-1490-2012 FDA Class I ·initiated 6 Jul 2011

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. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

• Terminated Z-0146-2011 FDA Unclassified (pre-2012) ·initiated 15 Sep 2010

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.