Events

Recall of SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15164
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Model / Serial
    Model Catalog: 35700BAX2 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    SPECTRUM INFUSION WITH MDL VERSION 8.0
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION