Sarns" Centrifugal System 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
    63079
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0050-2013
  • 사례 출판 날짜
    2012-10-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-01-15
  • 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
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • 원인
    Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2004 of various malfunctions of the battery backup system for the sarns" centrifugal system. the reports can be broadly categorized as follows: " failure to charge " failure to hold charge " failure to operate in the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. in.
  • 조치
    TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. TCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delphin Battery with additional instruction on the use and charging of a discharged battery. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; place the addendum in the Operator's Manual; and confirm receipt of the communication by faxing or emailing the attached Customer Response Form. For questions customers were instructed to call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CENTRO AMERICA, CHILE, COLOMBIA, Dominican Republic, Ecuador, FRANCE, GERMANY, GREECE, Guatamala, HOLLAND, HONG KONG, India, ITALY, Japan, KL SEGUNDO, KOREA, LEICESTERSHIRE, MALAYSA, Malaysia, Mexico, Mexico, Mexico, NETHERLANDS, Panama, Peru, Philippines, RALEIGH, Republic of Georgia, SANTIAGO CHILE, Saudi Arabia, SEOUL KOREA, SHANGHAI, CHINA, Singapore, South Africa, SPAIN, SWITZERLAND, TAIWAN, Thailand, UNITED ARAB EMIRATES (UAE), Uruguay, USA, and Venezuela,
  • 제품 설명
    Battery, 220V (Includes charger and connecting cable) || The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA