Events

Non Flow-Stop CADD® Medication Cassette Reservoirs 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 Smiths Medical 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
  • 사례 연번
    2018-114
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/498910-fda-advisory-no-2018-114
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2018-114 voluntary recall of cadd® medication cassette reservoir, part number 21-7001-24, 21-7002-24 and 21-7100-24  the food and drug administration (fda) informs the public and all healthcare concerned professionals that smiths medical manufacturer of above mentioned product with delex pharma international inc. as their distributor has voluntarily recalled certain lots of 50 and 100ml non flow-stop cadd® medication cassette reservoirs, part numbers 21-7001-24, 21-7002-24 and 21-7100-24. smiths medical informed the fda that certain non flow-stop cadd® medication cassette reservoirs, may have been manufactured with an incorrect pressure plate. when the cassette is attached to the pump, the tubing could be restricted, such that it is partially or completely occluded. the occlusion could pose risk to the patient of no delivery risk to health: the immediate impact to the patient depends on the patient condition, the therapy involved, and possibly the time to discover problem. potential health consequence due to no delivery may result in immediate or delayed effects. the severity of adverse effects, as well as the risk of long term consequences, can depend on the specific medication and the patient’s current or existing condition. the risk may occur when the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product, and coordinate with delex pharma international inc. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. attachments: fda advisory no. 2018-114.Pdf.

Device

Non Flow-Stop CADD® Medication Cassette Reservoirs
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical