Events

Recall of Graseby 3300 Pump and Graseby 3000 Series Accessories

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01146-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01146-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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