Events

Rappel de T34L and NIKI T34 Ambulatory syringe pumps

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par REM Systems 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-00245-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-30
  • 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-00245-1
  • 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
    Caesarea medical electronics (cme) has received reports of syringe pumps niki t34/t34l stopping and activating an alarm condition when being used in direct sunlight. if the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient.
  • Action
    The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.

Device

T34L and NIKI T34 Ambulatory syringe pumps
  • Modèle / numéro de série
    T34L and NIKI T34 Ambulatory syringe pumpsCaesarea Medical Electronics T34L Syringe PumpsCatalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ, CE-100-109PSLAU All Pumps and Pump Housings manufactured from 2013 onwards Caesarea Medical Electronics NIKI T34 Syringe Pumps Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS All Pumps and Pump Housings manufactured from 2013 onwards ARTG Number: 131232
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd