Events

All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet Software 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira 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-2013-RN-00189-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00189-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    There is a potential for the distal (occlusion) pressure sensor pin to break on plum a+ infusers. the distal pressure sensor pin is part of the overall subsystem that measures the pressure within the distal line of the administration set and indicated the presence of a full or partial distal occlusion. a broken distal pressure pin can only be detected via a visual inspection of the distal pressure pin.
  • 조치
    Hospira has provided work around instructions in the customer letter to identify and mitigate the issue temporarily.To further address this issue, Hospira is in the process of redesigning the distal pressure sensor pin to improve its strength and reduce the potential for breakage. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption of therapy or an under/over-infusion could result in serious injury or death.

Device

All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pum...
  • 모델명 / 제조번호(시리얼번호)
    All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet SoftwarePlum A+Single Channel Infusion PumpCatalogue Number: 611239101Number on Pump: 12391 & 11971Plum A+ Infusion Pump with MedNet SoftwareCatalogue Number: 612079201Number on Pump: 20792Plum A+3 Infusion Pump with MedNet SoftwareCatalogue Number: 612067801Number on Pump: 20678
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Australia Pty Ltd

Manufacturer

Hospira Australia Pty Ltd
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA