SIGMA SPECTRUM Infusion System (V8 Platform) (2021-03-17)

Starting date:

March 17, 2021

Posting date:

April 1, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75287

Last updated:
2021-04-01

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  Reason
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  Affected products

Affected Products 

SIGMA SPECTRUM Infusion System (V8 Platform)

Reason

Baxter is communicating important safety information regarding the practice of using multiple extension sets with infusion pumps. Increasing the length of IV tubing between the pump and the patient will result in varying increases in outlet pressure and/or decreases in intake pressure, which could lead to unknown and undetectable reductions in forward flow and flow rate accuracy.

Affected products