Events

BD Alaris System PC unit Model 8015 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 BD 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
    2017-07-26
  • 사례 출판 날짜
    2017-07-26
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170726b.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: bd alaris system pc unit model 8015 the health sciences authority (hsa) of singapore has posted a medical device safety alert regarding alaris system pc unit model 8015, manufactured by bd. according to the safety alert issued by the manufacturer, system error 255-16-275 can occur when a user selects two functions at the same time/rapid succession or not following typical workflows. this results in a synchronization issue between the pc unit and the modules. below are five examples: closing the pump module door and in rapid succession (less than 1 second apart) pressing start. priming and starting system in pause state and then attempting to remove the new syringe. starting an infusion using the delay options. then confirming the delay entry and pressing channel select on another module at the same time. locking pca door before confirming on screen popup that occurs on another module. pressing channel off on two syringe modules after completion of infusions at the same time. the system error would result in a non-silence-able, high priority alarm and status indicator lights on modules will flash red. the pc unit displays an error code of 255-16-275. if the system error occurs, all attached modules that are actively infusing will continue to infuse without the ability to titrate infusion parameters. the user may decide to reboot the system or re-program the device to titrate the infusion and/or to silence the alarms. this could result in the clinical decision to interrupt the infusions. an interruption in infusion can result in serious injury. the affected alaris system will not need to be remediated. affected users are instructed to refer to the user manual addendum to avoid the occurrence of this system error. for details, please refer to the hsa website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/june.Html posted on 26 july 2017.

Device

BD Alaris System PC unit Model 8015
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BD Alaris System PC unit Model 8015
  • Manufacturer
    BD

Manufacturer

BD