Events

ADVIA, Brand: Siemens, Hazard class I, Models :. - Centaur XP Immunoassay, Record: 10345160484 ;. - Centaur, Registration: 10345160020 .. Serial number attached (Distribution map) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics 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
    1517
  • 날짜
    2014-11-10
  • 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 manufacturer's information, if the connector tube is cracked and leaking, and the user does not replace the fluid bottles in the yellow warning system and the tank is empty, the system will signal results with an error signal since the fault of acid / base solution is detected. In this case, a limited number of test results processed before the error signal (up to 20 tests) can be affected and not flagged; however, several subsequent signal errors would indicate that a system malfunction has occurred and that the results need to be verified. #### UPDATED ON 08/21/2017, 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
    As described by the record holder, a problem was found in the fluid reservoir connector tube of the advia centaur and advia centaur xp immunoassay systems. a small break in the plug tube in the reservoir connector may occur due to mechanical stress. breakage may result in minimal dripping over the reservoir or the tray located below the reservoirs. there is a potential for leakage of a minimal amount of fluids out of the system.
  • 조치
    The registration keeper advises customers: 1. Immediately replace the vial for all fluids when the yellow alert appears. This will reduce the possibility of improper dispensing of fluids. 2. Refer to the ADVIA Centaur or ADVIA Centaur XP Operator's Manual for the bottle replacement procedure. 3. Use Personal Protective Equipment (PPE) when in contact with any liquid leaking from the system. 4. Examine the system for any fluid in the flask of the vials. If fluid is present, contact the Siemens Customer Care Center (0800-129-633) or your local Siemens technical support representative to schedule a visit. In addition, Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

ADVIA, Brand: Siemens, Hazard class I, Models :. - Centaur XP Immunoassay, Record: 10345160484 ;....

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc.