Events

Alerta De Seguridad para INSULIN INFUSION PUMPS: (1) H-TRON, (2) H-TRONPLUS V100

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por SISTEMAS AG DISETRONIC MEDICAL.

¿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
    89
  • Fecha
    2001-05-14
  • 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
    01) BRAZIL - OCTOBER 01, 2001 - ONE-HUNDRED COMPANY, PRODUCT REGISTRATION DETERMINATOR INSULIN H-TRONPLUS V100 INFUSION PUMP, REQUESTED THE ALTERATION OF LABELING OF THE PRODUCT REFERRED TO ANVISA. AS A CORRECTIVE ACTION, WITHDRAWAL THE HERMETIC SYSTEM IDENTIFIER (COMPLETELY CLOSED), ISSUED A SUPPLEMENT TO THE INSTRUCTION MANUAL FOR INSULIN H-TRON AND H-TONS PLUS PUMPS WITH SAYING: ATTENTION. AVOID ANY PUMP CONTACT WITH WATER. WATER PENETRATION MAY INTERFERE IN THE PROGRAMMING OF INSULIN OR PUMP DOSAGE AND THE ALARMS MAY BE DAMAGED. THIS MAY RESULT IN A LOWER OR LOWER DELIVERY OF INSULIN COULD CAUSE SEVERE HYPOGLYCEREMIA (LOW SUGAR IN BLOOD) -------------------------- -------------------------------------------- 02) BRAZIL MAY 21 2002 - ONE-HUNDRED COMPANY, PRODUCT REGISTRATION DETECTOR INSULIN H-TRONPLUS V100 INFUSION PUMP, MADE TOGETHER ANVISA ALTERATION OF LABELING OF THE REFERRED PRODUCT. OFFICIAL JOURNAL OF THE UNION - RE-RESOLUTION No. 567, OF APRIL 4, 2002 - PART TWO
  • Causa
    Ecri checked water into the insulin pump h-tronplus v100 was registered as "water test" for surface activities. this results in a case of infusion of the quantity equivalent to 8 days of treatment in just 45 minutes. the patient was diving on the surface, breathing a tube to observe the background of the sea and the manufacturer that said that there was no problems with this type of activity. the bombe examination demonstrated a screen in the "h" and "m" buttons and a condensation inside the display. if you believe that the water is penetrated by the fissure and caused the super infusion. the pump was not returned to the manufacturer. the manufacturer, however, issued an alert letter on march 14, 2001, informing patients of the potential problem, and a supplement to the manual.
  • Acción
    SEE THE CHARTER AND SUPPLEMENT OF THE MANUAL ON THE INTERNET: HTTP://WWW.DISETRONI-USA.COM ECRI AND THE MANUFACTURER RECOMMEND: (1) AVOID THAT BOTH PUMPS MINE. REMOVE THEM BEFORE BEGINING ACTIVITIES THAT SUBMIT THEM. (2) FOLLOW THE CHART INSTRUCTIONS, ONLY SWITCH THE POWER PACKS IN THE DRY ENVIRONMENT. WHILE REPLACING THE BATTERIES, MAKE SURE THE BLACK RING IS INSTALLED AND PROPERLY SEATED. (3) IF THE PUMP IS EVILUAL, BE INSPECTED TO CHECK THAT THEIR OPERATION IS CORRECT AND WATER INLET. BE ALERT TO SYMPTOMS OF SUPER-INFUSION: NERVOUS, HYPOTHERMIA, HEADACHE AND CONFUSION, SOME SEASONS OF CONVULSIONS AND EAT. FOR FURTHER INFORMATION CONTACT THE MANUFACTURER ON PHONE 0021-1-763-795-2000.

Device

INSULIN INFUSION PUMPS: (1) H-TRON, (2) H-TRONPLUS V100

Manufacturer

SISTEMAS AG DISETRONIC MEDICAL
  • Source
    ANVSANVISA