Events

Recall of 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-01335-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01335-1
  • 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
    Two issues have been identified with the plum 360 infusion system involving the distal occlusion auto restart (doar) feature and preventative maintenance (pm) due notification.Issue 1 - if the doar feature is enabled and a distal occlusion occurs, the pump will be in a "paused" state. if a malfunction alarm occurs while the pump is in the paused state waiting for the distal pressure to decrease, the pump cannot be turned off nor delivery restarted until the battery is discharged or disconnected. once the battery is recharged or reconnected, the pump can be returned to clinical service.Issue 2 - when the pm screen is accessed from the main biomed settings menu on pumps that have accumulated a total delivery time greater than 1500 hours, the user will not be able to interact with the pump and the pump must be power cycled. once this is done, the pump can be returned to clinical service. there have been no reports of a serious injury or death related to these issues.
  • Action
    For Issue 1: Hospira is providing work around instructions for users to follow as a interim measure. For Issue 2: Hospira is advising users to not enable the optional Preventative Maintenance Due Notification feature. A software update will be implemented as a permanent correction.

Device

Plum 360 Infusion System
  • Model / Serial
    Plum 360 Infusion SystemSoftware version: 15.10.00.010List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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