Events

Rappel de Radiometer ABL90 Series Blood Gas Analysers

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Radiometer Medical ApS.

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
    21043
  • Date de mise en oeuvre de l'événement
    2017-01-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Cause
    On the abl90 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. the selected sample type is displayed correctly on the abl90 series analyzer itself. irrespective of the sample type selected on the abl90 series analyzer during sample processing, the analyzer will transmit the less specific sample type cord blood to a his/lis or middleware system., an operator who is aware that the sample types that can be selected on the abl90 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., error may in a worst-case scenario lead to minor fetal hypoxic stress not being immediately recognized if the clinician was to use data from the his/lis or middleware system to determine treatment., this may cause a delay of treatment for newvborn infant.
  • Action
    Software to be upgraded

Device

Radiometer ABL90 Series Blood Gas Analysers

Manufacturer

Radiometer Medical ApS