Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SISTEMAS AG DISETRONIC MEDICAL.

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
    89
  • Date
    2001-05-14
  • 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
    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
  • Reason
    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.
  • Action
    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