Events

Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL ST01: 71HF30DB00, 71HF30DB00, 71HF30D00, 71HF30DD00, 71HF30DD00, 71HH19DA00, 71HH19D0000, 71HH19D0000, 71HH19DD00, 71HI05DA00, 71HI05DB00, 71HI12DA00, 71HI09DA00, 71HI11DA00, 71HI15DA00, 71HI12DA00, 71HI16DA00, 71HI17DA00, 71HI18DA00, 71HI19DA00 -. b) TYPE VL ST02: 71HE31DF00, 71HE29DA00, 71HE31DF00, 71HE29DB00, 71HE30DA00, 71HE30DB00, 71HE30DC00, 71HE31DA00, 71HE31DB00, 71HE31DC00, 71HE31DD00, 71HG15DA00, 71HG15DC00, 71HG15DB00, 71HG15DB00, 71HG15DC00, 71HG17DA00, 71HG15DD00, 71HG17DB00, 71HG22DC00, 71HG22DD00, 71HG15DD00, 71HG17DA00, 71HG22DC00, 71HH19DI00, 71HH19DK00, 71HH21DB00, 71HH21DC00, 71HH26DC00. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Fresenius Hemocare Brasil 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
    1447
  • 날짜
    2014-10-17
  • 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
    According to the company, the divergence in information does not risk the patient, considering that the product is in fact free of DEHP. The divergence of information is in the place of symbols. The DEHP free information is correctly described on the label. The company also informs that this product is of exclusive use for pump of infusion and restricted to the hospital scope. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • 원인
    The company informs that an error was identified in the labeling of the product. the product is exempt from dehp, and this information appears on the label, i do not understand in the area where the symbols of "barren, single-use product, keep out of moisture, among others" were misprinted, the symbol "contains dehp ". the difference in the contains and does not contain deph symbol is only a transverse trait.
  • 조치
    The company forwarded communication to customers who have already received the product stating the error.

Device

Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL S...

Manufacturer

Fresenius Hemocare Brasil Ltda.