Events

2008T Hemodialysis Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Renal Therapies Group, LLC 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
    79239
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0829-2018
  • 사례 시작날짜
    2017-10-05
  • 사례 출판 날짜
    2018-02-20
  • 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=161733
  • 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
    While reviewing documentation for the next software release of the 2008t, an r&d; technician identified that setting the uf goal to '0' introduces a discrepancy between the uf rate displayed and the actual uf pump rate. the software anomaly is also applicable to the 2008t machines that contained the 2.63 bug fix per dcaf 17-088. 2008t upgrade kits that contained the 2.63 bug fix are also affected. additionally, sw version 2.64 (in design freeze) is also impacted by this anomaly.
  • 조치
    Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.

Device

2008T Hemodialysis Delivery System
  • 모델명 / 제조번호(시리얼번호)
    2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX  190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su;
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    2008T, Hemodialysis Delivery System || Product Indicated for acute and chronic dialysis therapy.
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • 제조사 주소
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA