Events

Recall of BODYGUARD 323 IV INFUSION PUMP - PUMP

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

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
    88051
  • Event Risk Class
    I
  • Event Initiated Date
    2015-01-29
  • 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
    Cme america has identified a software issue with the bodyguard 323 that results in an over-infusion of medication without alarm. for the over-infusion to occur specific set-up conditions must exist at the same time. serious injuries and/or deaths could occur due to the failure mode associated with this recall.

Device

BODYGUARD 323 IV INFUSION PUMP - PUMP
  • Model / Serial
    Model Catalog: BODYGUARD 323 (Lot serial: S/N 71462); Model Catalog: BODYGUARD 323 (Lot serial: S/N 71309); Model Catalog: BODYGUARD 323 (Lot serial: S/N 69370); Model Catalog: BODYGUARD 323 (Lot serial: S/N 71329)
  • Product Description
    BodyGuard 323 Infusion Pump
  • Manufacturer
    CME AMERICA LLC

Manufacturer

CME AMERICA LLC
  • Manufacturer Address
    GOLDEN
  • Manufacturer Parent Company (2017)
    CME America, LLC
  • Source
    HC