Heater Unit HU 35 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-00917-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Getinge has released revised disinfection procedure for heater unit hu 35. heater unit hu 35 is used during extracorporeal life support (ecls) in intensive care units to maintain the patient’s blood temperature via an oxygenator heat exchanger. there is no contact between the blood stream of the patient and the system water circulating through the heat exchanger. maquet cardiopulmonary as well as different national competent authorities have received isolated reports confirming the presence of bacterial contamination in the system water of hu 35 including mycobacterial counts. however, maquet cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection would have been caused by a heater unit hu 35.
  • 조치
    The current published Instructions for Use chapter 6 “Cleaning and Disinfection” for HU 35 Heater Units will be replaced by a new Instructions for Use (IFU). Action to be taken by the user: 1. Complete and return the enclosed Acknowledgement Form as soon as possible to your local Maquet representative; 2. Incorporate this revised procedure into your operating processes; 3. Conduct any training necessary for the revisions; 4. Continue to monitor the hygiene (contamination levels) in accordance with your internal practices; 5. Immediately report any contamination findings to your local Maquet representative by a complaint; and 6. Remind all users that the HU35 is not to be opened or filled in the operating room.

Device

  • 모델명 / 제조번호(시리얼번호)
    Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
  • Manufacturer

Manufacturer