Events

Device Recall Abacus 3.1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Corporation Englewood 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
    68256
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1847-2014
  • 사례 시작날짜
    2014-05-28
  • 사례 출판 날짜
    2014-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127226
  • 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
    System/device, pharmacy compounding - Product Code NEP
  • 원인
    Baxter corporation is initiating a field correction following an upgrade to abacus software v3.1, when clinimix 4.25110 is used in an order, the nutritional summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
  • 조치
    Baxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to fca@baxter.com. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.

Device

Device Recall Abacus 3.1
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 8300-0167, 8300-0168, 8300-0169
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution and the state of VA.
  • 제품 설명
    Abacus 3.1, Pharmacy Calculator || Product Usage: || Provide pharmacy calculations for automated compounding.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • 제조사 주소
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA