Events

ALTHIN 1000 Series Hemodialisation Machine 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
    704
  • 날짜
    2003-04-03
  • 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
    Make sure you received equipment repair form dated March 24, 2003. Fill in and return to Baxter. For more information contact Baxter Hospitalar Ltda, phone: 11-5694850 or your local representative. Note: The company informs that this equipment repair is only a notification. You are not asking for the equipment to be returned or removed from use. To date there are no reports of occurrences of the events described here in installed equipment.
  • 원인
    The programmed 100 system conductivity alarm limits are checked and confirmed during the machine self-test. when sodium level is changed during therapy, new conductivity alarm limits are automatically restored based on new operator programming. identified the existence of a sequence of events that may delay the reestablishment of the new conductivity alarm limits, when the sodium level is programmed to higher values ​​than previously used. this delay can only occur if the dialysate or extracorporeal alarms also occur within seven minutes of changing the sodium. if dialysis is being performed using sodium chloride-free bicarbonate concentrates (fresenius or cobe / gambro) and occurs in the sequence of events below, this may lead to metabolic acidosis. - sodium increase above 8meq / l. - extracorporeal alarms or continuous or recurrent dialysis alarms, starting seven minutes after increasing sodium levels. - stopping the bicarbonate concentrate pump before the new conductivity limits are established it is important to note that if the dialysis is being carried out using bicarbonate concentrate with sodium chloride, any to the bicarbonate pump would be detected, not being applied so the sequence of events described above.
  • 조치
    Baxter will be reconfiguring by changing the BA alarm limits of the 1000 system hemodialysis machine ensuring its correct operation. These changes will prevent the undetected delivery of acid bath in the occurrence of a change in sodium level above 8 meq / L. The 1000 system operator and service manuals are being updated to reflect changes in calibration constants. The company informs you that upon receipt of the completed form you will be sending the updated section of the operation and service manual.

Device

ALTHIN 1000 Series Hemodialisation Machine

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA