Events

Recall of Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral)

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-2017-RN-00049-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00049-1
  • 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
    Based on overseas reports from a customer, bd/carefusion identified regarding a potential risk of syringe siphonage with pumps that have a broken “plunger back plate spring” in the plunger back plate assembly. a breakage of the plunger backplate spring may allow movement of the syringe plunger within the plunger holder mechanism which could result in siphonage. in some circumstances, this may result in a clinically significant over infusion especially in neonatal and paediatric patients, or those receiving critical drugs, at low infusion rates.
  • Action
    CareFusion is advising users to check the age of the pump by referring to the label on the rear case and to replace the plunger backplate spring (refer to Information Notice IN0221) on syringe pumps older than three years. Clinical areas such as neonatal, paediatric and critical care, where critical drugs are delivered at lower infusion rates are to be prioritised. In the event that users see a "Check Syringe" alarm without an identifiable cause, they are requested to remove the pump from clinical use for examination by a qualified service personnel in accordance with the Alaris Syringe Pump Technical Service Manual.

Device

Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral)
  • Model / Serial
    Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral) - All VariantsProduct Codes: with prefix 8001, 8002, 8003, 8004 and 8005 (all variants)All Serial NumbersARTG Number: 177501
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd