Events

Recall of Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion System

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-2017-RN-01336-1
  • Event Risk Class
    Class I
  • 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-01336-1
  • 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
    Icu medical has identified issues with hospira labelled mednet medication management suite versions 6.1 and 6.21 when used with plum 360 drug library management that occurs during the import of a plum 360 drug library.The mednet meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. this includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback.A change to a piggyback rule set could result in a delay initiating a therapy or interruption of an active infusion. this issue could also lead to mixing of two infusion solutions. if two mixed solutions are incompatible particulates could form or, if during a transfusion, a blood clot could form in the administration set. in rare circumstances, these conditions could lead to serious adverse health consequences.
  • Action
    ICU Medical is advising users that the issue arises during an import of a Plum 360 drug library. Users who have performed an import of a Plum 360 drug library or have the need to do so should refer to the information provided to customers to confirm if the drug library is affected during the import. A correction to the issues will be addressed in MedNet version 6.3.

Device

Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion System
  • Model / Serial
    Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion SystemVersion 6.1List Number: 16037-75-01Version 6.21List Number: 16037-75-02ARTG Number: 262489 (Hospira Pty Limited - Infusion pump medication dosage application software)
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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