Events

Rappel de ON-Q C-BLOC

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDQUEST MEDICAL INC..

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
    82530
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2012-06-22
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    I-flow recently determined that in a small quantity of on-q pumps with ondemand the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition the patient may receive continuous infusion at a rate greater than expected.

Device

ON-Q C-BLOC
  • Modèle / numéro de série
    Model Catalog: CB003 (Lot serial: Products having a 10-digit); Model Catalog: CB006 (Lot serial: are NOT impacted by this); Model Catalog: CB003 (Lot serial: lot#s that is >0200521454); Model Catalog: CB006 (Lot serial: lot#s that is >0200521454); Model Catalog: CB003 (Lot serial: (ie. 0200521455 and greater)); Model Catalog: CB006 (Lot serial: Products having a 10-digit); Model Catalog: CB003 (Lot serial: recall.); Model Catalog: CB006 (Lot serial: recall.); Model Catalog: CB003 (Lot serial: are NOT impacted by this); Model Catalog: CB006 (Lot serial: (ie. 0200521455 and greater))
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    ON Q C-BLOC WITH ONDEMAND (MODEL # CB003 & MODEL # CB006)
  • Manufacturer
    MEDQUEST MEDICAL INC.

Manufacturer

MEDQUEST MEDICAL INC.