Events

Device Recall The Terumo Advanced Perfusion System 1 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
    61480
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1966-2012
  • 사례 시작날짜
    2012-06-22
  • 사례 출판 날짜
    2012-07-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108194
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    Terumo advanced perfusion system 1 battery charge is being depleted faster than expected during periods of system shutdown. the system 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. this may result in unexpected system shutdown. prolonged battery depletion may cause permanent battery damage.
  • 조치
    TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Recall Notice, assure that all users are aware of the notice. Consignees should place the Addendum at the beginning of the System Base Section (page 3-1) of the Operator's manual, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number indicated on the form. All System 1 product is on quality hold. Terumo CVS will release product including batteries as needed only in the event that customers require service. All affected System 1 customers will receive a safety notification and an addendum to the Operator's Manual. There will be a field correction but no product returned for this recall. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

Device Recall The Terumo Advanced Perfusion System 1
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to: Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam,
  • 제품 설명
    System 1 Base, 220/240V || The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The System 1 base includes an integrated backup battery in the event of power loss.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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