Events

Alerte Ou Avis De Sécurité sur Infusion pumps

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hospira.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2013/004
  • Date
    2013-02-06
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-infusion-pumps-plum-a-single-channel-infuser-systems-risk-of-interruption-in-therapy
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    (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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Adresse du fabricant
    John McIlvaney Customer Services Manager Hospira UK Queensway Royal Leamington Spa CV31 3RW Tel: 0800 028 7304 Fax: 0800 028 7305Email: custserv@hospira.com
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA