Events

Device Recall Smiths Medical Medfusion infusion pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD, 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
    53940
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0651-2010
  • 사례 시작날짜
    2009-11-16
  • 사례 출판 날짜
    2010-01-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86903
  • 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 pump - Product Code FRN
  • 원인
    Smiths medical has become aware of an increased trend in reports of motor not running (mnr) and motor rate error (mre) alarm message events with certain medfusion¿ syringe infusion pumps, models 3010a and 3500 (pump). mnr/ mre are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the pump. the pump is designed so that when its so.
  • 조치
    An Urgent Medical Device Recall letter, dated November 16, 2009, was sent to customers beginning November 16, 2009. The letter described the issue, identified affected devices, and asked that affected devices be returned to Smiths Medical to be inspected, repaired, if necessary, and returned back to medical facility. A Confirmation Form is also asked to be completed and returned to Smiths Medical. To return Pumps or for questions regarding this Urgent Recall Notice, please contact Smiths Medical Customer Service Department at 1~866-270-7060. Please report any issues with these Pumps please contact Smiths Medical Technical Customer Service Department at 1866-216-8806.

Device

Device Recall Smiths Medical Medfusion infusion pump
  • 모델명 / 제조번호(시리얼번호)
    serial number: M66331, M66332, M66333, M66334, M66335, M66336, M66337, M66339, M66340, M66341, M66342, M66343, M66344, M66345, M66721, M66722, M66723, M66724, M66725, M66726, M66727, M66728, M66729, M66730, M66731, M66732, M66733, M66734.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates.
  • 제품 설명
    Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA)
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • 제조사 주소
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA