Events

MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2014-RN-00536-2
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00536-2
  • 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
    Baxter has received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
  • 조치
    Hospitals and distributors are asked to locate and return all the affected products at their facility. Health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. For more details, please see http://www.tga.gov.au/safety/alerts-device-minicap-extended-life-pd-140515.htm .This action has been closed-out on 29/01/2016.

Device

MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)

Manufacturer

Baxter Healthcare Pty Ltd