Events

Recall of Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Kabi Australia 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-01324-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01324-1
  • 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
    Fresenius kabi has identified a failure involved with the power adapter. in some cases a spark or short circuit has been reported on the wall socket used to connect the curlin 6000 and painsmart pumps. this failure does not affect the pump itself.
  • Action
    Fresenius Kabi is replacing all affected adapters with an improved adapter. In the meantime to mitigate any risk of injury customers are advised to use the device on the battery power and not use the adapter. The adapter is optional and is required only if the pump is to run on AC mains. Hence the pump can be used without the adapter.

Device

Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory
  • Model / Serial
    Curlin 6000 Painsmart IOD Infusion Pump Power Adapter AccessoryUsed with: Moog Curlin 6000 Ambulatory Infusion Pump and Moog Painsmart IOD Infusion PumpARTG Number: 225964 (Fresenius Kabi Australia Pty Limited - Infusion pump, analgesic, patient-controlled)
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd