Events

EXTERNAL PUMP OF INSULIN PARADIGM INFUSION. Models: MMT-515, MMT-715, MMT-522, MMT-722. Anvisa Records: 10339190274/10339190306. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDTRONIC COMERCIAL LTDA. 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
    1245
  • 날짜
    2013-04-12
  • 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
    POSSIBLE HEALTH HAZARDS: 1) Loose engine support cover: Pump user reports and analysis of returned pumps have indicated that, in some cases, the engine support cap may come loose from the pump case and project from the pump. lower right side of the pump. 2) Water Damage: Exposure to water may result in an alarm from the pump, damage to the internal electronics of the pump or cause the buttons to stop working. See information from the Letter to the User at http://portal.anvisa.gov.br/wps/wcm/connect/52ba94004f450ac8b80ef8d785749fbd/Carta+ao+Usu%C3%A3rio+-+Paradigm.pdf?MOD=AJPERES. #### UPDATE: Field action completed by the company on 12/19/2013.
  • 원인
    1) bottom engine support cover - the pump motor support cover is attached to the pump main housing during the production process. this support cap keeps the pump motor fixed and allows the engine piston to be pressed against the reservoir cap to send the insulin. 2) damage caused by water - exposure to water has been observed to result in damage to the internal electronics of the pump and may trigger the pump alarm or cause the buttons to stop working.
  • 조치
    TO USERS: 1) ENGINE SUPPORT COVER: Check your pump regularly, especially after impact or fall on a hard surface. If the engine support cover is designed as shown in the picture (see User's Letter), do not depress this part of the pump and discontinue use. 2) DAMAGE CAUSED BY WATER: To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after leaving the water. If your insulin pump is accidentally submerged, dry the pump quickly using a soft dry towel and check that it is working properly by selecting the Self-Test from the Utilities Menu of the insulin pump. If you believe the water has entered your insulin pump or notice any other possible malfunction of the insulin pump, check your blood glucose, treat the high blood glucose level (if needed) with an injection, and contact with your HelpLine or representative for help. The field action consists of sending information letter to customers and was initiated by the company on 03/28/2013.

Device

EXTERNAL PUMP OF INSULIN PARADIGM INFUSION. Models: MMT-515, MMT-715, MMT-522, MMT-722. Anvisa Re...

Manufacturer

MEDTRONIC COMERCIAL LTDA.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA