Events

Rappel de Radiometer ABL90Flex analysers running V3.1MR1 or below

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific 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-2014-RN-01365-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • 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-2014-RN-01365-1
  • 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
    Radiometer has recently become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds. if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating “please close the inlet”the problem can occur after the following sequence of actions:1. the operator aspirates patient sample a and forgets to close the inlet 2. the inlet is left open for more than 30 seconds before it is closed3. an operator aspirates patient sample bin this case the results for patient sample b are affected by this issue.Radiometer is currently developing a mechanism to be included in a future software upgrade to eliminate the possibility of this error. a label to be attached to the machine is provided to re-inforce the correct instructions for use.
  • Action
    Operators are reminded of the requirement to close the inlet when prompted by the analyser, as per the labelling and the Operator Manual. In the event the inlet is left open by mistake, a series of corrective steps is provided to customers as an interim measure. A warning label is also provided to customers to attach to the machine to re-inforce the correct instructions for use. Customers are advised that a look back over previous results may be required at the discretion of the Medical Director Radiometer is currently developing a mechanism to be included in a future software upgrade that will eliminate the possibility of this error. This action has been closed-out on 20/04/2017.

Device

Radiometer ABL90Flex analysers running V3.1MR1 or below
  • Modèle / numéro de série
    Radiometer ABL90Flex analysers running V3.1MR1 or belowARTG Number: 228382An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd