Events

MiniMed Silhouette and MiniMed Sure-T infusion sets 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-11-11
  • 사례 출판 날짜
    2014-11-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141111a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic minimed silhouette and minimed sure-t infusion sets medical device manufacturer, medtronic limited, has issued a medical device safety alert concerning its minimed silhouette and minimed sure-t infusion sets. as part of its global quality monitoring process, the manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the minimed silhouette and minimed sure-t infusion sets. if tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify the patient. the interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health, including death. symptoms of dka may include nausea, vomiting, shortness of breath and excess thirst/urination. patients should seek medical attention immediately if they experience any of these symptoms. according to the manufacturer, patients can continue to use their infusion sets by following the advice below: when changing the infusion set, patients should closely follow the instructions for use included in the product box. they should check the tubing at the site connector location identified in the drawings above to make sure it is not loose. as always, it is essential to monitor blood sugar levels frequently using a blood glucose meter. they should proactively check the tubing connections occasionally throughout the day to ensure tubing is secure. it is especially important to check blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.. if the patients experience a high blood sugar, they should check the tubing connections and infusion site closely to ensure tubing is secure. if the patients discover the tubing is detached, they should follow the instructions below: do not attempt to reattach the tubing. they should replace the infusion set immediately. treat any high blood sugar based on the guidelines provided. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2014.

Device

MiniMed Silhouette and MiniMed Sure-T infusion sets
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic MiniMed Silhouette and MiniMed Sure-T infusion sets
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH