Events

Device Recall HomeChoice PRO 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
    30693
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0397-05
  • 사례 시작날짜
    2004-12-23
  • 사례 출판 날짜
    2005-01-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36407
  • 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
    A software anomaly may allow concentrated solution to be infused into the patient when the homechoice unit is used with physioneal clear-flex pd products.
  • 조치
    Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.

Device

Device Recall HomeChoice PRO
  • 모델명 / 제조번호(시리얼번호)
    Units with software version 8.7 used with Physioneal Clear-Flex PD products
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
  • 제품 설명
    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

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