Events

Alerte De Sécurité sur HEMODIALYSIS MACHINE DBB-06, Registration no. 80145240398, serial number: all series produced before September 2012, with the exception of the series 73030-5. See numbers of affected series in the annex .. http://portal.anvisa.gov.br/wps/wcm/connect/7d89b7804e316945950ab7c09d49251b/Number+of+Series+Afetados.pdf?MOD=AJPERES

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
    1221
  • Date
    2013-01-15
  • 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
    Although no adverse event is reported, the company reports that DBB-06 hemodialysis equipment may have additional risks for patients with CVC and undergo hemodialysis treatment. According to IEC 60601-2-16 currently harmonized in Brazil, patient leakage current in DBB-06 devices is classified as "type B" (lesser degree of requirement for permissible leakage current), but the new IEC 60601-2-16 (4th Edition) defines that hemodialysis equipment, when in use by patients with CVCs, must comply with the "CF type" patient leakage current limits (higher degree of the permissible leakage current). The corrective action will be performed to meet the requirements of the 4th Edition of the IEC 60601-2-16 standard not yet harmonized in Brazil. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    Excessive leakage current in patients when in therapy using dbb-6 equipment in combination with a central venous catheter (cvc).
  • Action
    The company requests the kindness to take the following actions: i. Consider that DBB-6 Hemodialysis Equipment may have additional risks for patients using CVC. Therefore, avoid the treatment of patients in critical condition or with known coronary disease. It recommends using other hemodialysis equipment available on your service for these patients until the update is done. NOTE: This does not affect the treatment of patients who undergo hemodialysis treatment and use fistula access. ii. Fill out the Customer Response form, confirming receipt of the letter and sending it by e-mail to faleconosco@baxter.com or by fax at (0XX 11) 5694-8827. The immediate return of the form will prevent the warning from being sent repeatedly. It is NOT necessary to return Nikkiso's "Security Alert Receipt Confirmation", only Baxter's. Baxter Hospitalar will initiate corrective action to be performed by field service engineers during annual preventive maintenance by updating DBB-06 equipment to conform to the "CF Type" rating for patient leakage current.

Device

HEMODIALYSIS MACHINE DBB-06, Registration no. 80145240398, serial number: all series produced bef...

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA