Events

Alerte De Sécurité sur HEMODIALISING MACHINE SPS-1550 (ANVISA Register: 10068390088).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1018
  • Date
    2010-05-07
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    According to Baxter Hospitalar Ltda, as a result of a field correction performed in 2003 by the company, some hemodialysis equipment of the SPS 1550 model may contain electronic boards with wrong versions of software. The correct software versions for 1550 devices are 4.1B (for System 4 equipment) and 3.0A (for System 3 equipment). Software versions other than those listed above (on the side panel of the machine) display the incorrect "USE UF MANUAL" message when code errors FL04, FL07 and FL08 occur. Correct software versions (3.0A and 4.1B) display the message "DISCOUNT TX" (TX = Treatment) in the occurrence of these same error codes. The company has already sent a letter of communication and is making available the correct software update for its clients. #### Update: The action was closed by the company in December 2010, according to a letter sent to UTVIG (File: 009119 / 11-7 , 05/01/2011). According to Baxter, all customers (286) were notified and visited by company technicians for software upgrades.
  • Cause
    The equipment may issue an incorrect instruction to the user, leading to continuation of hemodialysis therapy in situations in which it should be discontinued.
  • Action
    To health facilities: If you have this equipment at your health facility, proceed as follows: (1) Identify the software version of your equipment, following the manufacturer's instructions (see attachment); (2) If the software version of your equipment is different from versions 3.0A or 4.1B, instruct equipment operators to discontinue the treatment whenever the dialer side panel reports error codes FL04, FL07 or FL08, disregarding the UF MANUAL "instruction that will appear (this message is incorrect for the mentioned error codes). It is highly recommended that a written, easily identifiable work instruction be placed near the equipment panel that alerts operators to the problem.

Device

HEMODIALISING MACHINE SPS-1550 (ANVISA Register: 10068390088).

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA