SPECTRUM INFUSION WITH MDL VERSION 8.0 (2015-03-06)

Starting date:

March 6, 2015

Posting date:

April 13, 2015

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-52831

• Reason
• Affected products

Recalled Products

A. SPECTRUM INFUSION WITH MDL VERSION 8.0

Reason

Baxter has identified a discrepancy between the loading/bolus default dose settings in the master drug library (MDL) version 8.0 and the values displayed on the pump during loading/bolus dose programming. When a drug's loading dose or bolus dose is configured in the MDL with a default starting time value in seconds, the loading dose or bolus dose setup screen on the pump will display the time value rounded to the nearest integer in minutes. When this occurs, the pump will administer drugs as configured. This discrepancy is only with the default time on the setup screen, not with the amount or rate of drugs administered, as configured in the drug library.

Affected products