Events

Recall of Sapphire Multi Therapy Pump with software Rev09Ver07 (Infusion Pump)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hospira Pty Limited.

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-2013-RN-01041-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01041-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    The manufacturer, q core, has received three similar reports from a customer, who experienced deviations from the duration of treatment, as programmed. the incidents occurred while using the multi step mode. while no patient injuries or deaths have been reported, the issue may result in incorrect therapy. specifically, the issue only occurs when the following conditions are met simultaneously:- multi-step mode is used, and- the pump is not plugged into an ac power outlet and is operating on battery power only, and- the pump backlight is turned off.The factory default for the backlight configuration in the sapphire multi therapy pump is on; therefore unless the pump backlight is turned off, the issue will not occur.
  • Action
    Q Core has developed a software solution (Rev09Ver08) to address the issue. Until the Sapphire Multi Therapy pumps have been updated with the new software, users are required to: (i)Use the Sapphire Multi Therapy pump plugged into an AC power outlet; and/or (ii)Use the Sapphire Multi Therapy pump with the backlight configuration set to ON or PARTIAL. It is recommended to check all pumps that are in current operation in order to ensure correct setting of the backlight. Please note that in pumps configured with backlight OFF the screen will darken completely after 1 minute of screen inactivity. The pumps configured to have the backlight OFF require reconfiguration of the backlight setting to ON.

Device

Sapphire Multi Therapy Pump with software Rev09Ver07 (Infusion Pump)
  • Model / Serial
    Sapphire Multi Therapy Pump with software Rev09Ver07 (Infusion Pump)Hospira List Number: 163113601ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA