Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Baxter Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 083 04 12 001
  • 사례 시작날짜
    2013-05-12
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3594
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Baxter would like to inform you that an error in the sequence of instructions in the direction inserts for the products listed above has been identified. in section 1 (set placement on cycler) under directions for use, step 1.3 instructs users to remove the protector from the patient line connector on the set prior to connecting solution bags. users should not remove the protector from the patient line connector on the set prior to connecting solution bags. the tip protector should be removed from the patient line connector after priming and immediately prior to connecting the patient line to the transfer set, as described in the in the homechoice and homechoice pro apd systems patient at-home guide. exposure of the patient line during setup can lead to touch contamination resulting in the potential for developing peritonitis. baxter is in the process of updating the direction inserts with the correct sequence of instructions.

Device

Disposable Set Tubing, HomeChoice Disposable Sets
  • 모델명 / 제조번호(시리얼번호)
    (1) R5C4478 HomeChoice Automated PO Set with Cassette 8-Prong; (2) R5C4479 HomeChoice Automated PO Set with Cassette 4-Prong . update code from MHRA HomeChoice disposable sets: R5C4455, R5C4478,R5C4479, R5C4479E see the attachment.
  • 제품 설명
    Disposable Set Tubing
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • 제조사 모회사 (2017)
    Baxter International
  • 제조사 대표
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA