Events

Rappel de HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00855-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-11
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00855-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Baxter healthcare has been made aware that users may not be following the instructions in the operator’s manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (pd) therapy, damaging the cassettes for the homechoice or homechoice pro cyclers. the homechoice cycler operator’s manual specifically warns the operator to open the disposable set packaging by hand and not use tools that may damage the cassette sheeting. do not use knives, scissors, clamp accessories, or other objects to open the disposable set packaging. if damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region, and the cycler may deliver air into the patient.
  • Action
    Baxter is requesting customers: 1. As stated in the At-Home Guide, open the packaging of the disposable set by hand. Do not use any sharp object to open the packaging; 2. Be aware that flow of fluid out of the connector at the end of the patient line after the prime phase of PD therapy is a visual indication of the potential for air delivery due to an undetected hole over the patient valve area in the cassette sheeting. Baxter will be updating the labelling to include this observation. 3. Complete the Customer Reply Form and return it as per the instructions in the customer letter; and 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.

Device

HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD System
  • Modèle / numéro de série
    HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD SystemHomeChoice PRO Automated PD Cycler, 230VProduct Code: R5C8320HomeChoice Claria APD System, 115V/230VProduct Code: 5C6M10All Serial NumbersARTG Number: 172780
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd