Events

Alerta De Seguridad para SINGLE CHANNEL VOLUMETRIC INFUSION PUMP POWER CABLES, COLLEAGUE

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BAXTER HEALTHCARE CORP.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    100
  • Fecha
    2001-04-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    BRAZIL, JANUARY 16, 2003: BAXTER HOSPITALAR INFORMES THAT THAT ACCORDING TO THE TECHNICAL SERVICE OF ITS COMPANY, THERE WAS NOT ANY OCCURRENCE THAT MENTIONED A SIMILAR CASE. ALSO NO OPENING OF ANY CALLS IN YOUR COMPLAINT SYSTEM. HAVING NO REGARD TO A SIMILAR CASE REGARDING NATIONALITY, BAXTER IS PROVIDED FOR OTHER CLARIFICATIONS. BRASIL, BRASILIA-DF, APRIL 24, 2003: BAXTER HOSPITALAR REPORTS THAT THE CORRECTIVE ACTION OF CABLES WAS NOT APPLIED TO BRAZIL, SINCE IT STARTED THE IMPORTATION OF THESE MACHINES SINCE THOSE EQUIPMENTS ARE BROUGHT WITH NEW CABLES. THE REFERENCE ACTION OCCURRED IN THE USA IN 2000 AND THE COMPANY STARTED IMPORTS OF THESE MACHINERY ONLY IN 2001.
  • Causa
    The manufacturer received reports regarding damage to the connection cables of the above infusion pumps mentioned. this damage may result in heating and potential burns from the area adjacent to the cable. the manufacturer began a correction by correspondence sent on april 24, 2001.
  • Acción
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SUBMITTED ON APRIL 24, 2001, THE INSTRUCTIONS FOR THE REPLACEMENT PROCEDURE AND THE BAXTER RESPONSE SHEET. IDENTIFY AND ISOLATE ANY AFFECTED PRODUCT IN YOUR STOCK. BAXTER RECOMMENDS THAT ALL POWER CORDS OF THE SINGLE COLLAGE CHANNEL PUMP BE REPLACED. BAXTER DECLARES THAT MOST RESISTANT CABLES WILL BE PROVIDED FREE OF CHARGE AFTER THE FILLING AND RETURN OF THE BAXTER RESPONSE SHEET BY FAX (847) 948-3948. BAXTER FURTHER INFORMES THAT THE IMMEDIATE RETURN OF THE RESPONSE SHEET WILL GUARANTEE THE INSERT OF THE CUSTOMER IN THE SUPPLY SCHEDULE. THE REPLACEMENT CABLES WILL BE IDENTIFIED BY THE "65 × 36" NUMBERS RECORDED IN THE ISOLATION COVER THROUGHOUT THE ENTIRE CAPE LENGTH. BAXTER RECOMMENDS THAT AFTER RECEIVING THE REPLACEMENT CABLE (S) THE USERS FOLLOW THE REPLACEMENT PROCEDURE INSTRUCTIONS MENTIONED IN THE CORRESPONDENCE AND (1) TRANSPORT THE PUMP BY THE PUMP LEVER AND NOT BY THE CABLE; (2) DISCONNECT THE WALL STRENGTH CABLE BY PULLING THE OUTLET AND NOT THE CABLE; AND (3) IF THE CABLE IS PACKED UP FOR TRANSIT / STORAGE, MAKE SURE IT ENOUGH CAPS AND IS PROPERLY PROTECTED. FOR FURTHER INFORMATION, PLEASE CONTACT THE SALES REPRESENTATIVE OF THE INFUSION SYSTEMS OR THE BAXTER SERVICE CENTER BY TEL. (888) 229-0001.

Device

SINGLE CHANNEL VOLUMETRIC INFUSION PUMP POWER CABLES, COLLEAGUE

Manufacturer

BAXTER HEALTHCARE CORP
  • Source
    ANVSANVISA