Events

Medfusion 4000 Syringe Infusion Pump 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2013-RN-01232-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01232-1
  • 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
    Smiths medical has identified an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may appear at the ac power receptacle. the pump and the ac power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. there is a potential for delay in treatment while a replacement or alternative method of delivery is obtained.
  • 조치
    Smiths Medical is advising users to immediately unplug the AC power cord from the power source if there are signs of sparking, flames or smoke emitting from the unit. Smiths Medical is providing work around instructions for users to follow until Smiths Medical develops a permanent fix.

Device

Medfusion 4000 Syringe Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    Medfusion 4000 Syringe Infusion PumpAll lot numbers affectedARTG Number: 122405
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd