Events

Recall of T34L and NIKI T34 Ambulatory syringe pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by REM Systems 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-2016-RN-00245-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00245-1
  • 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
    Caesarea medical electronics (cme) has received reports of syringe pumps niki t34/t34l stopping and activating an alarm condition when being used in direct sunlight. if the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient.
  • Action
    The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.

Device

T34L and NIKI T34 Ambulatory syringe pumps
  • Model / Serial
    T34L and NIKI T34 Ambulatory syringe pumpsCaesarea Medical Electronics T34L Syringe PumpsCatalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ, CE-100-109PSLAU All Pumps and Pump Housings manufactured from 2013 onwards Caesarea Medical Electronics NIKI T34 Syringe Pumps Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS All Pumps and Pump Housings manufactured from 2013 onwards ARTG Number: 131232
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd