Events

Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Kabi Australia 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-2017-RN-01324-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01324-1
  • 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
    Fresenius kabi has identified a failure involved with the power adapter. in some cases a spark or short circuit has been reported on the wall socket used to connect the curlin 6000 and painsmart pumps. this failure does not affect the pump itself.
  • 조치
    Fresenius Kabi is replacing all affected adapters with an improved adapter. In the meantime to mitigate any risk of injury customers are advised to use the device on the battery power and not use the adapter. The adapter is optional and is required only if the pump is to run on AC mains. Hence the pump can be used without the adapter.

Device

Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory
  • 모델명 / 제조번호(시리얼번호)
    Curlin 6000 Painsmart IOD Infusion Pump Power Adapter AccessoryUsed with: Moog Curlin 6000 Ambulatory Infusion Pump and Moog Painsmart IOD Infusion PumpARTG Number: 225964 (Fresenius Kabi Australia Pty Limited - Infusion pump, analgesic, patient-controlled)
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd