Events

Recall of RAPIDPoint 500 Blood Gas Analyzer

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-2015-RN-00700-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00700-1
  • 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 is informing customers of potential issue when both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data, missing data and data from a different patient. the risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. a transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
  • Action
    Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update. This action has been closed-out on 01/03/2018.

Device

RAPIDPoint 500 Blood Gas Analyzer

Manufacturer

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