Events

Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Alaris Medical Systems Inc 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
    237
  • 날짜
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The uk medical devices agency (mda) has issued a safety note informing hospitals that it continues to receive reports of high doses of infusion resulting from user-free flowing by mismanaging the devices of the pumps mentioned. the mda states that poorly handled apparatus can interfere with the pump mechanism, resulting in a free flow at the start of the infusion. while the infusion happens the assembly positions correctly and the fluid adjusts to the set of programmed instructions. the mda states that in such cases, even if the user can detect the high doses of infusion by examining the amount of fluid in the bag, the inadequate loading will not be detected, since the assembly will not be properly positioned. in addition, the infused volume display will not show the wrong extra volume due to the initial free-flow.
  • 조치
    MDA recommends the following: (1) Ensure that the assembly loading instructions are followed at the time of fitting of the equipment in the Pump Models 597 and 598. (2) Do not operate the orange lock before the lower set adapter is fully inserted into the air-in-line switch. (3) Do not close the door before operating the orange latch. (4) Make sure that no fluid is present and that no drop is dripping into the chamber at the time of opening of the assembly clamp prior to the start of infusion. For further factory information, contact your local representative or directly with Carlos Sepulveda, Alaris Medical Systems, by mail at the above address, by phone / fax 0021-44-2- (125) 633 0860 ..

Device

Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598

Manufacturer

Alaris Medical Systems Inc
  • Source
    ANVSANVISA