Events

Safety Alert Or Field Safety Notices for 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 Hospira.

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/2013/004
  • Date
    2013-02-06
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-infusion-pumps-plum-a-single-channel-infuser-systems-risk-of-interruption-in-therapy
  • 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
    Risk of interruption in therapy due to clinical staff failing to hear the alarm.The operation of the alarm volume control is not consistent with the operator’s manual. On some pumps, the knob is turned clockwise to increase the volume, on others, it is anticlockwise.Hospira will be updating the user manual and providing labels for each device to identify the correct operating direction.
  • Reason
    (hospira) clinical staff failing to hear an audible alarm. (mda/2013/004).
  • Action
    Ensure members of staff are aware that the alarm volume level control is not the same on all these pumps. Ensure that relevant members of staff are familiar with the steps to check the alarm as described in the manufacturer’s Field Safety Notice (dated 29 October 2012), in particular the need to confirm the volume level before beginning therapy. Contact Hospira to arrange for volume direction labels to be fixed to all devices. If you have more than one device being used in the same location and they do not have the same alarm volume control, you may contact Hospira for adjustment of the direction of the volume control to ensure consistency.

Device

Infusion pumps
  • Model / Serial
  • Product Description
    Infusion pumps: Plum A+ single channel infuser systems.Manufactured by Hospira.Product codes: 11005, 11971, 12391, 20792.The following single channel infuser systems are affected by this alert:Plum A+ hyperbaric infusion system. Affected product code: 11005 Plum A+ single channel infusion system. Affected product codes: 11971 + 12391 Plum A+ infusion pump. Affected product code: 20792.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Address
    John McIlvaney Customer Services Manager Hospira UK Queensway Royal Leamington Spa CV31 3RW Tel: 0800 028 7304 Fax: 0800 028 7305Email: custserv@hospira.com
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA