Events

Recall of RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-01098-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01098-1
  • 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
    Siemens has identified that when all of a particular set of steps occur there is a potential for the first and/or last name of one patient to be printed with patient id and result data from a different patient, even when those fields have been turned off for the system. the steps are: 1. analyser is configured with patient demographics (last name, first name) disabled and rapid sample identification transaction (host query) turned on. 2. patient id barcode is scanned at analysis screen prior to sample being analysed and is not the barcode for the patient sample being tested. 3. patient id and last name are not confirmed and/or corrected at the analysis screen. 4. the sample is analysed and correct patient id is entered at demographics screen.An incorrect patient name on the blood gas printout has the potential to lead to patient mismanagement.The patient id and patient test result data are correct on the analyser screen and the lis.
  • Action
    Siemens is advising users to not configure the Siemens Blood Gas Analyser with the patient demographics (last name, first name) turned Off and the Rapid Sample Identification Option turned On. In addition, if sample IDs are scanned at the analysis screen, users should confirm that the patient ID is correct on the screen prior to analysing the sample. And, if the patient ID is not correct, correct it at the analysis screen.

Device

RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An...
  • Model / Serial
    RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).Various models affectedARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA