Events

Device Recall HomeChoice Automated PD system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare 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
    77711
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3041-2017
  • 사례 시작날짜
    2017-07-05
  • 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=157849
  • 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, peritoneal, automatic delivery - Product Code FKX
  • 원인
    Baxter healthcare corporation has been made aware that users may not be following the instructions in the operators manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their peritoneal dialysis (pd) therapy, damaging the cassettes for the homechoice or homechoice pro cyclers. if damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.
  • 조치
    The firm notified their consignees by letter on 07/05/2017 of the potential for damaging the disposable set if tools are used to open the packaging and directing them to only open the packaging by hand by letter.

Device

Device Recall HomeChoice Automated PD system
  • 모델명 / 제조번호(시리얼번호)
    all codes
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R || Product Usage: || The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • 제조사 주소
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA