Device Recall Plum A Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira Inc. 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
    64263
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0287-2014
  • 사례 시작날짜
    2013-02-01
  • 사례 출판 날짜
    2013-11-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Plum a+ infusers have the potential for the distal (occlusion) press sensor pin to break. the distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. a broken distal pin can only be detected via a visual inspection of the distal pressure pin. a broken.
  • 조치
    Hospira sent an Urgent Device Field Correction letter dated February 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter recommends that facilities immediately visually inspect their Plum a+ devices to determine if the distal pressure pin is broken or damaged via instructions included in the letter. If a broken or damaged distal pressure pin is observed, remove the device from service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to report the issue. If the return of defective pumps significantly impairs a facility's ability to operate normally, Hospira will provide loaner pumps. The letter also encourages customers to insert cassettes into pumps in accordance with the instructions found in the operator's manual. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to call 1-800-441-4100 or 1-800-241-4002, option 4. The letter also asked direct accounts that further distributed the pumps notify their customers of the URGENT DEVICE FIELD CORRECTION and ask them to contact Stericycle at 1-866-201-9068 to receive a reply form.. For questions regarding this recall call 800-441-4100,

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
  • 제품 설명
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. || The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
  • Manufacturer

Manufacturer

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