Events

BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: 10068390005, code 5C4482, all existing batches. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Hospitalar Ltda.; Baxter Healthcare Corporation 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
    1728
  • 날짜
    2015-10-30
  • 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 manufacturer's information, the risk of improper use of transfer equipment for peritoneal dialysis may result in contamination. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    Identified absence of information on product label.
  • 조치
    Update of the instructions for use. The recommendation will be included on the label to monitor the function of the thyroid in nursing or child patients, as there is the remote risk of change. The need to use aseptic technique in order to avoid contamination leading to infection or peritonitis will be reinforced. Changes to the instructions for use include: • This equipment should be used with the Baxter Titanium Adapter for the peritoneal dialysis catheter for disconnection and for connections to the Homechoice cycler where aseptic connections and disconnections are made at the junction of the extension of the catheter; //// • For connection and exchange of the Equipment, the Transfer Team Exchange technique provided by the Baxter Clinic Team must be followed. ///// It is recommended that thyroid function be monitored in patients with small volumes of peritoneal dialysate filling, typically infants or children; //// Reprocessing or reusing single use equipment can lead to contamination and impairment of the function or structural integrity of the equipment; /// Do not use if the guards are not in place; //// This product does not contain natural rubber latex. ////////// Baxter requests that patients be advised by clinics and hospitals about these changes that will be made in the instructions for use and that the importance of following the instructions for use of the products is emphasized. (SEE LETTER TO THE CLIENT). Action code: FCA2013-013

Device

BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: ...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare Corporation