Events

HyperHypothermia System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero Products Inc 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
    60721
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0969-2012
  • 사례 시작날짜
    2011-10-27
  • 사례 출판 날짜
    2012-02-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106307
  • 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
    System, thermal regulating - Product Code DWJ
  • 원인
    The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of aids or cancer patients, were not appropriately cleared by the fda prior to distribution.
  • 조치
    CSZ sent an "URGENT: FIELD ACTION NOTICE" letter dated January 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to become familiar with the amended manual page and to get approvals from the Institutional Review Board before further use of the device. Additionally, a response form was enclosed with the letter for customers to complete and return via fax to (513)772-9119. Contact CSZ Service Department at 1-800-989-7373 for questions regarding this notice.

Device

HyperHypothermia System
  • 모델명 / 제조번호(시리얼번호)
    Blanketrol ll 48¿C - Models 222 & 222R Hyper-Hypothermia Systems: Serial Numbers: 902-8645, 902-8646, 911-9426, 914-10001, 914-10140, 914-10177, 943-12074, 992-14052, 994-14290, 994-14291, 002-14541, 002-14545, 012-15024, 014-15260, 022-15490, 074-18981, 962-12825, and 874-6277.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.
  • 제품 설명
    Blanketrol II 48¿C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48¿C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. || The 48¿C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA