Baxter Meridian Hemodialysis Instrument 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Renal Div 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
    33632
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0275-06
  • 사례 출판 날짜
    2005-12-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-11-27
  • 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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • 원인
    Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.
  • 조치
    Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams showing the correct and incorrect use of the clips, provided labels, with placement instructions, to be placed on the Meridian machine indicating the correct and incorrect placement of tubing, and informed the users that replacement clips with single channels will be installed when they become available. Follow-up letters were sent to the accounts on 12/22/05, providing training material to ensure that the accounts are aware of proper blood tubing set-up and understand the conditions which may result in hemolysis, and on 12/23/05, informing them that the replacement clips were available for installation, giving the accounts the option of having Baxter install them or sending the clips to the account for self-installation.

Device

  • 모델명 / 제조번호(시리얼번호)
    all serial numbers, beginning with 20000
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally to Mexico and Asia.
  • 제품 설명
    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA