Events

HEMODIALYSIS MACHINE DBB-06, Registration no. 80145240398, serial number: all series produced before September 2012, with the exception of the series 73030-5. See numbers of affected series in the annex .. http://portal.anvisa.gov.br/wps/wcm/connect/7d89b7804e316945950ab7c09d49251b/Number+of+Series+Afetados.pdf?MOD=AJPERES 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Hospitalar 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
    1221
  • 날짜
    2013-01-15
  • 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
    Although no adverse event is reported, the company reports that DBB-06 hemodialysis equipment may have additional risks for patients with CVC and undergo hemodialysis treatment. According to IEC 60601-2-16 currently harmonized in Brazil, patient leakage current in DBB-06 devices is classified as "type B" (lesser degree of requirement for permissible leakage current), but the new IEC 60601-2-16 (4th Edition) defines that hemodialysis equipment, when in use by patients with CVCs, must comply with the "CF type" patient leakage current limits (higher degree of the permissible leakage current). The corrective action will be performed to meet the requirements of the 4th Edition of the IEC 60601-2-16 standard not yet harmonized in Brazil. #### 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
    Excessive leakage current in patients when in therapy using dbb-6 equipment in combination with a central venous catheter (cvc).
  • 조치
    The company requests the kindness to take the following actions: i. Consider that DBB-6 Hemodialysis Equipment may have additional risks for patients using CVC. Therefore, avoid the treatment of patients in critical condition or with known coronary disease. It recommends using other hemodialysis equipment available on your service for these patients until the update is done. NOTE: This does not affect the treatment of patients who undergo hemodialysis treatment and use fistula access. ii. Fill out the Customer Response form, confirming receipt of the letter and sending it by e-mail to faleconosco@baxter.com or by fax at (0XX 11) 5694-8827. The immediate return of the form will prevent the warning from being sent repeatedly. It is NOT necessary to return Nikkiso's "Security Alert Receipt Confirmation", only Baxter's. Baxter Hospitalar will initiate corrective action to be performed by field service engineers during annual preventive maintenance by updating DBB-06 equipment to conform to the "CF Type" rating for patient leakage current.

Device

HEMODIALYSIS MACHINE DBB-06, Registration no. 80145240398, serial number: all series produced bef...

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA