Events

Device Recall Fresenius 2008 Series Hemodialysis Machines 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Holdings, Inc. 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
    66622
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0629-2014
  • 사례 시작날짜
    2013-11-12
  • 사례 출판 날짜
    2014-01-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122784
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 원인
    2008 series hemodialysis machines complaints of saline bags inappropriately filling during recirculation and setup.
  • 조치
    Fresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who encounter a saline bag that is inappropriately filling, should discontinue the setup and remove the machine from service until the drain line and drain-associated hydraulic components can be checed by a qualified service technician. Customers were also instructed to ensure that the hemodialysis machine is installed and operated in compliance with the Machine Specification section of their operator's manual, including the specification located in the Water/Drain Section. Customers with questions were instructed to call 1-800-227-2572. For questions regarding this recall call 800-662-1237.

Device

Device Recall Fresenius 2008 Series Hemodialysis Machines
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
  • 제품 설명
    Fresenius 2008 Series Hemodialysis Machines: || Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T || The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA