Events

Device Recall Plum 360 Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira Inc., A Pfizer Company 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
    76253
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1682-2017
  • 사례 시작날짜
    2016-12-30
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152590
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Pump, infusion - Product Code FRN
  • 원인
    Depleted battery alarm shows instead of replace battery. on battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. on ac power, the pump reboots (takes about 25 seconds). therapy can resume. ac power interruption of 3-7 seconds prompts an incorrect e323 alarm, ongoing therapy stop, and pump reboot. longer power loss results in battery power operation.
  • 조치
    On 12/30/2016, firm sent notification of the recall to Hospira direct consignees of record via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Effectiveness of the communication will be confirmed by phone call with direct consignees who do not respond. The final disposition of the recalled product will be field correction (firm will contact consignees to upgrade the software in their Plum 360 infusion pumps).

Device

Device Recall Plum 360 Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
  • 제품 설명
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
  • Manufacturer
    Hospira Inc., A Pfizer Company

Manufacturer

Hospira Inc., A Pfizer Company
  • 제조사 주소
    Hospira Inc., A Pfizer Company, 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    USFDA