Events

Alerte De Sécurité sur HomeChoice Automated Peritoneal Dialysis system, 230V

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter Healthcare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-21
  • Date de publication de l'événement
    2013-10-21
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131021.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: baxter homechoice automated peritoneal dialysis system, 230v medical device manufacturer, baxter healthcare, has issued a field safety notice concerning homechoice automated peritoneal dialysis system, 230v (product code: 5c4474; software version: v10.4). baxter is sending a communication to describe homechoice 10.4 software initial drin logic in patients with unrelated co-morbid condition of ascites. ascites is the abnormal accumulation of fluid in the peritoneal cavity. peritoneal dialysis patients with ascites may have large volumes of fluid in their peritoneal cavity. when these patients drain significant amounts of ascetic fluid (e.G. more than 5 liters), studies suggest that medical intervention may be required to mitigate against developing hypotension and potential hemodynamic compromise. homechoice software is designed to empty the peritoneal cavity during initial drain. previous versions of homechoice software permitted the operator to stop the active initial drain and bypass it. the current version of the homechoice software version 10.4 removed the option to bypass an active initial drain in order to mitigate against unintended increased intraperitoneal volume. patients diagnosed with the co-morid condition of ascites who drain to empty may be at an increase risk of hypotension and compromise of their hemodynamic status. therefore, baxter advises that clinicians using the homechoice to treat patients diagnosed with end stage renal disease coincident with ascites should: be aware that homechoice will attempt to drain the patient to empty at the beginning of therapy (initial drain) review homechoice ifu for additional details on homechoice 10.4 initial drain logic. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 october 2013.

Device

HomeChoice Automated Peritoneal Dialysis system, 230V
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system, 230V
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare