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
    21718
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-13
  • 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 received complaints for repeated system error 322 "link switch error (low)" occurrences with the sigma spectrum infusion system. this error may occur when there is a miscommunication with the two internal switches that detect door closure. if system error 322 occurs during infusion the sigma spectrum infusion system stops infusing. an audible alarm and visual alarm will also occur.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Model / Serial
    Model Catalog: 35700BAXT (Lot serial: >1000 NUMBERS (CONTACT MFR)); Model Catalog: 35700BAX (Lot serial: >1000 NUMBERS (CONTACT MFR)); Model Catalog: 35700 (Lot serial: >1000 NUMBERS (CONTACT MFR))
  • Product Description
    SIGMA SPECTRUM INFUSION SYSTEM W/ MDL
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION