Events

Alerte Ou Avis De Sécurité sur Diacap® Ultra dialysis fluid filter

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 B. Braun Avitum AG.

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
  • ID de l'événement
    MDA/2013/033
  • Numéro de l'événement
    CON272262
  • Date
    2013-05-10
  • Date de publication de l'événement
    2013-05-10
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272262?tabName=allTabs
  • 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
  • Cause
    Risk of a gradual increased fluid removal, which may cause symptoms of hypotension during dialysis treatment. ultrafiltration deviations may not be immediately detected by the machine. this is due to a decrease in the residual moisture of the filter membrane, which can cause a higher fluid removal from the patient than initially selected. it has been noted that over time the residual moisture of the membrane used in the diacap ultra dialysis fluid filter decreases leading to an alteration in the membrane permeability, which in turn affects the device flow resistance. when used clinically, the altered functionality of the device can lead to excess fluid of up to 230 ml/hr, being removed under worst case conditions. although the haemodialysis system will alarm at a set value beyond the pre-set ultrafiltration rate, the higher ultrafiltration rate has the potential to cause symptoms of hypotension in some patients.
  • Action
    Identify quarantine and do not use affected devices. Ensure that all staff are aware of the manufacturer’s Field Safety Notice (FSN) dated 22 February 2013. Develop a system to ensure that these devices are not used more than 10 months from the date of manufacture, until the manufacturer advises otherwise. Return the ‘confirmation of receipt’ form in the FSN to the manufacturer. Contact B. Braun Medical Ltd, Sheffield to arrange replacement of affected product.

Device

Diacap® Ultra dialysis fluid filter
  • Modèle / numéro de série
  • Description du dispositif
    Diacap® Ultra dialysis fluid filter. Product code: 7107366. All devices that are more than 10 months from the date of manufacture are affected. This device is used as a bacteria and pyrogen filter for dialysis fluid purification, as well as for processing substitution solution for online haemodiafiltration and haemofiltration procedures. The date on the label is in the format YYYY-MM e.g. 2012-07 for July 2012. The month of manufacture in this case is July 2012 which should be counted as month one when calculating the age of filters. Therefore, product manufactured in July 2012 should not be used after April 2013. See Field Safety Notice for further information.
  • Manufacturer
    B. Braun Avitum AG

Manufacturer

B. Braun Avitum AG