Events

Recall of Alaris System PC Unit (PCU) model 8015, software version 9.12

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-2013-RN-00707-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00707-1
  • 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
    In the affected devices, the keyboard processor is operating at an incorrect voltage. the correct voltage should be at 1.8 volts however the affected units are at 1.4 volts. due to this issue the alaris system pcu software v9.12 while in operation could potentially experience a loss of communication between the pcu main processor and keyboard processor. the alaris system pcu will display either a system error (error codes 111.2000 or 111.2002) or channel disconnected error message. along with the pcu display the alaris system pcu also produces an audible alarm and the attached modules will display a scrolling "communication error" message. during the communication error, the pump will alarm both visually and audibly.
  • Action
    Customers are asked to weigh the risk/benefit to patients before continuing to use the affected PCU, version 9.12. Either discontinue use of affected PC units until remediated or continue use on patients by implementing work around instruction identified in the customer letter. CareFusion Technical Service will provide a software update to correct the voltage on the keyboard processor for those affected Alaris System PC units.

Device

Alaris System PC Unit (PCU) model 8015, software version 9.12
  • Model / Serial
    Alaris System PC Unit (PCU) model 8015, software version 9.12Multiple serial numbers affectedARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd