Events

T34L and NIKI T34 Ambulatory syringe pumps 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 REM Systems Pty Ltd 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
    RC-2016-RN-00245-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00245-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Caesarea medical electronics (cme) has received reports of syringe pumps niki t34/t34l stopping and activating an alarm condition when being used in direct sunlight. if the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient.
  • 조치
    The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.

Device

T34L and NIKI T34 Ambulatory syringe pumps
  • 모델명 / 제조번호(시리얼번호)
    T34L and NIKI T34 Ambulatory syringe pumpsCaesarea Medical Electronics T34L Syringe PumpsCatalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ, CE-100-109PSLAU All Pumps and Pump Housings manufactured from 2013 onwards Caesarea Medical Electronics NIKI T34 Syringe Pumps Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS All Pumps and Pump Housings manufactured from 2013 onwards ARTG Number: 131232
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd