Events

Safety Alert Or Field Safety Notices for All T34 ambulatory syringe pumps

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Caesarea Medical Electronics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2018/010
  • Date
    2018-03-28
  • Event Date Posted
    2018-03-28
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-t34-ambulatory-syringe-pumps-risk-of-unintended-pump-shutdown-and-delay-to-treatment
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    The manufacturer has identified that there can be a +/- 2mm overall size difference between battery brands used with CME’s T34 ambulatory syringe pumps.This could result in battery movement within the battery housing leading to a possible loss of connection. This may result in the pump shutting down.Be aware that if the pump’s battery connectors and/or housing are inadvertently damaged during these checks, and the pump is outside of the warranty period, the manufacturer may charge for pump repair/replacement.
  • Reason
    Manufactured by caesarea medical electronics (cme) ltd – a variation in battery size can cause problems with connections in the battery housing. (mda/2018/010).

Device

All T34 ambulatory syringe pumps

Manufacturer

Caesarea Medical Electronics