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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- 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
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