Device Recall Abacus TPN Calculating Software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxa Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52013
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1436-2012
  • 사례 시작날짜
    2009-01-19
  • 사례 출판 날짜
    2012-05-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Medical computers and software - Product Code LNX
  • 원인
    Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
  • 조치
    Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalogue Numbers:  8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME)
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
  • 제품 설명
    Abacus TPN Calculating Software || Product Usage: || LIMS Windows-based program for order entry and TPN calculation.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • 제조사 모회사 (2017)
  • Source
    USFDA