Events

CADDSolis Medication Safety Software 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
    69408
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0166-2015
  • 사례 출판 날짜
    2014-11-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130449
  • 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, infusion, pca - Product Code MEA
  • 원인
    Smiths medical has identified an issue with a single batch (lot number 2752712) of cadd"-solis medication safety software administrator 3.1 cds. cadd"-solis medication safety software administrator 3.1 cds were sent with the cadd"-solis medication safety software point of care 3.1 software loaded on them.
  • 조치
    Consignees were hand delivered by Smiths Medical Sales representatives on 9/29/2014 a Smiths Medical "Urgent Field Safety Notice" dated 25-September-14. The letter described the problem and the product being recalled. The letter also provided the Advice on Action to be Taken by the User, Transmission of this Urgent Medical Device Recall Notice and requested consignees to complete and return the Confirmation Form by fax to 1-800-237-8033 or via email to recall.response@smiths-medical.com. For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.

Device

CADDSolis Medication Safety Software
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 2752712
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
  • 제품 설명
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. || Product Usage: || The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
  • 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