Events

Rappel de Graseby 3300 Pump and Graseby 3000 Series Accessories

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-2017-RN-01146-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-06
  • 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-2017-RN-01146-1
  • 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
    Smiths medical has become aware that in certain cases, the lock and key supplied with graseby 3300 pumps and accessories does not match the standard graseby 3300 key. affected products were either serviced or manufactured between 30 oct 2015 and 06 apr 2016.In affected cases, the key provided will operate the lock, but cannot be shared between affected pumps and other graseby 3300 pumps as it should. the key is needed to unlock the pump’s security cover to allow programming of infusion, changing of program settings, restarting infusion or allow clinician overrides. it is also required for operation of the ratcheting type pole clamp (described as the “locking” type): the lock must be operated to remove the pump from the pole and to reposition the pump on the pole.A mismatch between the lock and key has the potential to delay the delivery of pain medication and lead to an increase in pain. to date, smiths medical has not received any reports of serious injuries related to this issue.
  • Action
    1. Complete and return the supplied Form even if you do not have any affected devices in your possession. 2. Locate all keys associated with GRASEBY pumps and locking accessories and visually inspect keys to ensure keys are labelled “95001”. Collect and isolate any keys not labelled “95001”. 3. Ensure all personnel with Graseby keys are using key “95001”. 4. Using the “95001” key, unlock and relock the locking mechanism on all GRASEBY pumps or locking accessories. 5. If the “95001” key does not successfully operate the locking mechanism, or if you do not have a “95001” key, discontinue use of the pump. 6. Return affected keys to Smiths Medical Australasia. A representative will contact you about scheduling replacement of the affected key. 7. Notify anyone to whom you have distributed this product.

Device

Graseby 3300 Pump and Graseby 3000 Series Accessories
  • Modèle / numéro de série
    Graseby 3300 Pump and Graseby 3000 Series AccessoriesGraseby 3300 PumpsModel Number: 0128-0001Lock AssemblyModel Number: 0128-0025Pole ClampModel Number: 0128-0135 and 0128-0136Security Cover KitModel Number: 0128-0451ARTG Number: 122405
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd