Events

Device Recall Terumo perfusion 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corp 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
    37367
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1002-2007
  • 사례 시작날짜
    2004-07-01
  • 사례 출판 날짜
    2007-07-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50430
  • 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
    Perfusion System - Product Code DTQ
  • 원인
    Roller pump: due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
  • 조치
    As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem

Device

Device Recall Terumo perfusion
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. Serial numbers 17525, 17697, 17899, 17904, 17905 and 17913 have been corrected.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.
  • 제품 설명
    Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA