Events

Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registration Number: 80554210002 Hazard Class: III Serial Numbers Affected: 1P04097 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Terumo BCT Tecnologia Médica Ltda.; Terumo BCT 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
    2319
  • 날짜
    2017-06-23
  • 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
    MEASURES TO BE ADOPTED BY OUR CUSTOMERS 1) Distribute this notice to all users of the Spectra Optia Apheresis System within their organizations. 2) Continue to use the Spectra Optia Apheresis System as instructed in the operator's manual. 3) Important: Fill out the receipt form and send it signed to the email andrea.wecchi@terumobct.com as soon as possible. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users.
  • 원인
    During routine testing of the manufacturing quality system, a terumo bct device that is similar to the spectra optia apheresis system demonstrated a non-recoverable power failure. a subsequent failure investigation determined that a power filter cable, a component used in the internal electrical system, had a visible defect causing the unit to lose power. further evaluation has determined that this defect may be present in other electrical cables that may cause a similar non-recoverable power failure. the cables were insulated in specific manufacturing batches. each spectra optia apheresis system also contains these cables described above. no other failures were noted in the manufacturing quality tests and there were no customer reports regarding a non-recoverable power failure related to any spectra optia apheresis system manufactured with the potentially affected cables.
  • 조치
    Field Action Code FA 25 triggered under the responsibility of the company Terumo BCT Tecnologia Médica LTDA. Company will make correction in the field.

Device

Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registrat...

Manufacturer

Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc.