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.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
데이터 추가 비고
원인
Clinicians using homechoice to treat patients diagnosed with end-stage kidney disease with ascites should be aware that homechoice will attempt to drain the patient to discharge at the beginning of therapy ("initial extract"). with homechoice 10.210 software, the user was allowed to stop the active initial spill and then bypass it. with homechoice 10.4 software, this functionality has been removed. drainage to discharge in patients with ascites-diagnosed comorbidity is associated with an increased risk of hypotension and serious impairment of their hemodynamic status.