Events

Alerte De Sécurité sur abl90 flex

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Radiometer.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-05-21
  • Date de publication de l'événement
    2018-05-21
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180521b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: radiometer abl90 flex medical device manufacturer, radiometer, has issued a medical device safety alert concerning its abl90 flex (393-090) analyzers running software versions 3.3 mr1 or lower. the manufacturer has become aware that the abl90 flex in a very rare specific situation can aspirate cal 2 solution instead of rinse solution. the specific situation can occur when the following take place: the analyzer is in ready mode operator lifts the inlet and then closes it again, thereby initiating a rinse immediately after lifts the inlet and quickly closes it again in this situation, it will lead to several parameters reported wrong during the following measurements. some of the parameters will not have an error message or question mark indicating a problem with the result. the wrong reporting will continue until the analyzer flow selector has reset. according to the manufacturer, the flow selector will reset as part of the automatic error removal process performed during repeated automatic calibrations, qc measurements or during installation of the solution pack. it will release a new software version 3.4 (933-470) for the abl90 flex analyzer, which correct this issue. the affected customers are advised to take the following actions: inform users of the abl90 flex analyzer that the inlet is not to be repeatedly lifted and closed. if this is done anyway the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. follow the procedure described in the instruction for use for installation of a solution pack. re-use the same solution pack. review previous results, where cna+ and ccl- results are off from the expected results with the values found in table 1 of the field safety notice. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 may 2018.

Device

abl90 flex
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Radiometer ABL90 FLEX
  • Manufacturer
    Radiometer

Manufacturer

Radiometer