SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (V6 & V8)

Starting date:

September 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-60532

• Reason
• Affected products

Affected Products

Reason

Baxter Corporation is issuing a device correction for the SIGMA Spectrum Infusion Pump with Master Drug Library (Spectrum Infusion Pump) in order to replace speakers installed in pumps that have an increased potential to fail prematurely. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum infusion pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.

Before using an affected spectrum infusion pump, users should confirm the generation of an audible tone, as instructed in the device operator manual.

Affected products