Events

Decapsmart, model Estorflow 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 MEDICA S.p.A. 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
    Field Safety Notice
  • 날짜
    2017-02-20
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    The aforementioned risk is as follows: if you press the plunger knob to the right during the normal procedure for replacing the heparin syringe, moving the plunger to the left by 1 ml when the heparin syringe has already been inserted into the tubing system and placed in the appropriate bay , the patient may be injected up to 9 ml anticoagulation solutions (heparin) due to automatic piston movement that cannot be controlled by the operator.   an overdose of heparin may cause the following problem in patients: bleeding or hemorrhage, including fatal outcome, depending on the concentration of solution used.   uncontrolled heparin injection can only occur if the procedure shown in the video is not followed consistently when using the device while replacing the syringe.

Device

Decapsmart, model Estorflow
  • 모델명 / 제조번호(시리얼번호)
    72000915, 72000114, 72002412, 72003813, 72002812, 72002912, 72000313, 72000815, 72000512
  • Manufacturer
    MEDICA S.p.A.

Manufacturer

MEDICA S.p.A.