Events

Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare 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
    36928
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0484-2007
  • 사례 시작날짜
    2006-12-06
  • 사례 출판 날짜
    2007-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49582
  • 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
    Infusion Pumps - Product Code FRN
  • 원인
    Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. if corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
  • 조치
    Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.

Device

Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers used in or near linear accelerator suites
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • 제품 설명
    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA