Events

Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems 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
    76386
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1235-2017
  • 사례 시작날짜
    2015-05-27
  • 사례 출판 날짜
    2017-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153034
  • 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
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • 원인
    Terumo cardiovascular systems corporation has received complaints indicating that the sarns centrifugal pump (disposable pump heads) have exhibited leaks. the leaks were detected during priming of the bypass circuit and during cpb procedures. in each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. terumo cardiovascular system's investigation into the incident has identified the cause of the leaks to be cracks in both the top housing and magnet back housing of the pump. when the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
  • 조치
    Customer Notification Letter/Response Form is being sent to all affected consignees.

Device

Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump
  • 모델명 / 제조번호(시리얼번호)
    TAOS, TC03
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
  • 제품 설명
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA