Events

Safety Alert for ADVIA, Brand: Siemens, Hazard class I, Models :. - Centaur XP Immunoassay, Record: 10345160484 ;. - Centaur, Registration: 10345160020 .. Serial number attached (Distribution map)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1517
  • Date
    2014-11-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    According to manufacturer's information, if the connector tube is cracked and leaking, and the user does not replace the fluid bottles in the yellow warning system and the tank is empty, the system will signal results with an error signal since the fault of acid / base solution is detected. In this case, a limited number of test results processed before the error signal (up to 20 tests) can be affected and not flagged; however, several subsequent signal errors would indicate that a system malfunction has occurred and that the results need to be verified. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    As described by the record holder, a problem was found in the fluid reservoir connector tube of the advia centaur and advia centaur xp immunoassay systems. a small break in the plug tube in the reservoir connector may occur due to mechanical stress. breakage may result in minimal dripping over the reservoir or the tray located below the reservoirs. there is a potential for leakage of a minimal amount of fluids out of the system.
  • Action
    The registration keeper advises customers: 1. Immediately replace the vial for all fluids when the yellow alert appears. This will reduce the possibility of improper dispensing of fluids. 2. Refer to the ADVIA Centaur or ADVIA Centaur XP Operator's Manual for the bottle replacement procedure. 3. Use Personal Protective Equipment (PPE) when in contact with any liquid leaking from the system. 4. Examine the system for any fluid in the flask of the vials. If fluid is present, contact the Siemens Customer Care Center (0800-129-633) or your local Siemens technical support representative to schedule a visit. In addition, Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

ADVIA, Brand: Siemens, Hazard class I, Models :. - Centaur XP Immunoassay, Record: 10345160484 ;....

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA