Events

Safety Alert Or Field Safety Notices for Plum 360 infusion 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 ICU Medical.

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
  • Date
    2018-02-15
  • Event Date Posted
    2018-02-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/plum-360-infusion-pumps-user-actions-required-to-prevent-risk-of-interrupted-infusion-or-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
  • Reason
    Manufactured by icu medical (formerly hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (mda/2018/006).
  • Action
    Identify affected pumps, which were manufactured from 29 April 2015 to 25 October 2016 inclusive – see the spreadsheet listing device serial numbers which accompanies this Medical Device Alert and the manufacturer’s Field Safety Notice (FSN). If you are still unsure, contact the manufacturer. Inspect affected pumps as detailed in the FSN. If a loose connectivity engine module or blank display is found, remove the pump immediately from service, and contact manufacturer for repair. If the pump powers down without an alarm, use an alternative pump, and contact manufacturer for repair. Assist manufacturer to schedule appointments for inspection/repair and ensure pumps are made available to manufacturer for inspection/repair at the scheduled time/date. Ensure you have read the Field Safety Notice and have completed and returned the acknowledgement form as currently the manufacturer has not received sufficient responses

Device

Plum 360 infusion pumps
  • Model / Serial
  • Product Description
    The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.
  • Manufacturer
    ICU Medical

Manufacturer

ICU Medical
  • Manufacturer Address
    ICU Medical Customer Service Tel: 020 3357 9400
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA