The Recall Desk
LowFDA (Devices)·Z-2030-2012·Announced 2012-07-25

Sigma Recalls Infusion Pump Master Drug Library Editor Software

Sigma issued a safety alert for the SIGMASpectrum Infusion Pump Master Drug Library Editor software because it may create drug libraries that do not reflect common clinical practices.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text identifies this as a safety alert regarding software that may not represent common clinical practices, without reporting any injuries, illnesses, or deaths. Per the rubric, documentation or software issues without reported harm are classified as Low severity.

Plain-English summary

Sigma has issued a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System. The software is used to create a customized in-house library of intravenous and epidural drugs, along with their safe delivery parameters.

The alert was issued because the software may result in a facility drug library that does not represent common clinical practices. This discrepancy could potentially impact the accuracy of drug delivery parameters within the infusion pump system.

The affected product includes 2,048 CDs containing all versions of the software. The product was distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Canada. Users of the SIGMA Spectrum Infusion Pump System should verify that their drug libraries align with current clinical standards and consult with their Sigma representative for further guidance.

The recalled product

Product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Manufacturer
Sigma
Category
Medical Device — Infusion Pump Software
Hazard
Affected units
2,048

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All versions

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · software error

See all →