Events

CADD Solis VIP 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
    76189
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1439-2017
  • 사례 시작날짜
    2016-10-31
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152490
  • 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
    20 pumps sold to the finnish market contain a message in which one word in the message is mistranslated. when the user follows a specific set of key presses the pump will display the incorrect message. the message indicates that a patient controlled analgesia (pca) dose is unavailable because the pump is running. it should indicate that the pca dose is not available because the pump is stopped. the function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
  • 조치
    Smiths Medical sent an Urgent Medical Device Field Safety Notice dated October 26, 2016, via FedEx on October 31, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to contact the Smiths Medical Service & Repair Department for the software to be loaded and to complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For further questions please call (651) 633-2556.

Device

CADD Solis VIP
  • 모델명 / 제조번호(시리얼번호)
    1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Internationally to Finland
  • 제품 설명
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
  • 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