Events

Device Recall Prismaflex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gambro Renal Products, Incorporated 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
    58208
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1901-2011
  • 사례 시작날짜
    2011-03-14
  • 사례 출판 날짜
    2011-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98675
  • 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.
  • 데이터 추가 비고
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 원인
    Prismaflex touch screen may become unresponsive during continuous renal replacement therapy procedure.
  • 조치
    The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).

Device

Device Recall Prismaflex
  • 모델명 / 제조번호(시리얼번호)
    All units with Version 3.20 software.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Prismaflex System, Catalog Number 107493, || Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • 제조사 주소
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA