Baxter Healthcare Corporation recalls Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spe…

Recall date

April 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1666-2018

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US Nationwide & Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. 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.