Events

Rappel de sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fresenius Medical Care Australia 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-2016-RN-01612-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-12-20
  • 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-2016-RN-01612-1
  • 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
    During the continuous monitoring of sleep safe tubing systems on the market, fresenius medical care has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes, and thus leakages may occur. the possible damage might not be visually detected. the sleep safe cycler can also not detect such a leakage. therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis. the problem of overwelded lines has been analysed and solved in subsequent production.
  • Action
    Fresenius will be contacting patients (users) via hospitals and organising the exchange of potentially affected stock with replacements. In the interim, users are to follow the detailed handling instructions provided in the customer letter. Users are reminded to: - Unroll carefully the tube coils of the sleep safe sets. - If unrolling is not possible, discard the sets. - If unrolling is successful, check carefully the patient line for leakages during priming. For more information, please refer to https://www.tga.gov.au/alert/sleep-safe-tubing-systems-used-peritoneal-dialysis .

Device

sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)
  • Modèle / numéro de série
    sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)sleep.safe SetBatch Numbers: XAS131, XCS241sleep.safe Set PlusBatch Numbers: XBS011, XBS252, XBS253, XCS221, XES09100, XES10100, XES12100, XES17100, XES31100sleep.safe Set PaedBatch Numbers: XAS221, XBS043ARTG number: 123388
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd