Device Recall S5 Double Roller Pump 85 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group Deutschland GmbH 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
    61375
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1326-2012
  • 사례 시작날짜
    2012-02-23
  • 사례 출판 날짜
    2012-03-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-11-27
  • 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.
  • 데이터 추가 비고
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.
  • 조치
    Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a replacement pump. Please complete and return the attached Confirmation Form by fax to 303-467-6502. Customers were instructed to ensure that the Urgent Field Safety Notice is distributed to all personnel in their organization who need to be aware of the notice. If the product was transferred to a third party, customers were asked to share the information with them as well as Sorin Group USA Customer Service at 1-800-850-2623. For questions regarding this Urgent Field Safety Notice, contact Sorin Group USA Customers Service at 1-800-650-2623. All affected customers and distributors were notified of the Field Correction by certified mail beginning on February 23, 2012. They will be contacted by Sorin Service Group to arrange an appointment to replace affected shaft encoders on site.

Device

  • 모델명 / 제조번호(시리얼번호)
    10E51342 to 10E51597
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    S5 Double Roller Pump 85 || The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA