Events

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

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 SISTEMAS AG DISETRONIC MEDICAL 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    89
  • 날짜
    2001-05-14
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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
  • 원인
    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.
  • 조치
    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