Device Recall Accura System for Blood Filtration 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
    32631
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1380-05
  • 사례 시작날짜
    2005-07-13
  • 사례 출판 날짜
    2005-08-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-10-29
  • 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
    In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy.
  • 조치
    Baxter sent Important Product Information letters dated 7/13/05 to all Accura device customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the on-going investigation into the potential self-test failure associated with the Accura instrument, and provided the customers with steps to follow if they encounter failed instrument self-tests. These guidance steps include: 1) Place the instrument into 'stand-by' mode. Generally, 15 minutes in 'stand-by' mode is sufficient to allow successful instrument self-test procedures. Enter 'stand-by' mode by turning off the power by using the upper power switch, or by selecting 'Accura off' from the user interface. Avoid selecting 'Next treatment' as this immediately puts the Accura into self-test mode. 2) After 15 minute, turn the power on. 3) After successful completion of self-test, resume therapy per the Accura Operator's Manual. 4) If the instrument still does not complete a successful self-test, additional time in 'stand-by' mode may be required. Repeat steps 1-3. 5) If repeated attempts do not yield a successful calibration test, then remove the instrument from service and contact Baxter Global Technical Services. Any questions were referred to the Center for One Baxter at 1-800-422-9837.

Device

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, and internationally to China and Belgium
  • 제품 설명
    Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany
  • Manufacturer

Manufacturer

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