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/2013/006
  • Date
    2013-02-20
  • 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-and-a-3-family-of-infusers-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 to treatment.If the pump is running on mains power and the software detects that the battery cannot be fully recharged, an alarm will sound and the infusion will stop.If this occurs the “E321” error message will be displayed.The MHRA continues to investigate this and other recent field safety corrective actions.
  • Reason
    (hospira) if pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (mda/2013/006).
  • Action
    Identify affected pumps. Consider using an alternative device, particularly if an interruption to an infusion could compromise patient safety. If an alternative is not available, follow the advice in the manufacturer’s Field Safety Notice (845Kb) (dated 19 February 2013) Ensure staff also follow the advice in other Field Safety Notices issued by the manufacturer for the following problems:  Volume control knob (457Kb) Door roller assembly (2746Kb) Distal pressure sensor calibration (61Kb) Fluid ingress (991Kb) Fluid shield diaphragm (84Kb) Distal pressure sensor pin fracture (92Kb) Recycling / rebooting (3252Kb)

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