HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Baxter Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-04-10
  • 사례 출판 날짜
    2013-04-10
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: baxter homechoice automated peritoneal dialysis system(patient at-home guide) medical device manufacturer, baxter healthcare, has issued a safety alert letter to customers to inform them of the best practice for properly managing a planned or emergency disconnect from their homechoice automated peritoneal dialysis (pd) system(product code 5c4474). the homechoice patient at-home guide (part number 071964016) describes using a flexicap or opticap for high dose therapy (optichoice therapy) or for an emergency disconnect. however, the flexicap or opticap are not available in hong kong. if patients disconnect during therapy and do not reconnect using new supplies, there may be a possible of contamination of the patient line, which may lead to peritonitis. baxter advises patients that if they need to disconnect from their therapy before it is completed, they should end the therapy and then restart the therapy using all new supplies (such as solution bags and the disposable set). according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (Patient At-Home Guide)
  • Manufacturer

Manufacturer