Maquet System CS 100, CS100i and CS 300 Intra-Aortic Balloon Pumps 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Maquet 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
    2017-06-20
  • 사례 출판 날짜
    2017-06-20
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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: maquet system cs 100, cs100i and cs 300 intra-aortic balloon pumps the united states food and drug administration (fda) has issued a medical device safety alert concerning system cs 100, cs100i and cs 300 intra-aortic balloon pumps (iabps), manufactured by maquet. the affected devices are identified as follows: cs100i iabp [part number: 0998-uc-0446hxx; 0998-uc-0479hxx] cs100 iabp [part number:0998-00-3013-xx; 0998-uc-3013-xx] cs300 iabp [part number: 0998-00-3023-xx; 0998-uc-3023-xx] this field correction also applies to any system 98 or system 98xt iabp that was converted to a cs100i or cs300 iabp. the manufacturer received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. this complaint involved a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the manufacturer indicates that the risk-benefit of using an affected cs100i, cs100 or cs300 iabp should be assessed by the medical team for each patient when no alternative iabp or alternative therapy is available. affected users are instructed to adhere to the following instructions when using affected devices: pursuant to the user instruction warnings, clinicians are instructed not to leave the patient unattended during iabp therapy. an additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. it is important to note the following warning in the cs100i, cs100 or cs300 iabp operating instructions manual: warning: the patient balloon should not remain inactive in the patient (i.E., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation. until the service is performed, the manufacturer recommends powering on the iabp prior to inserting the iab catheter to allow the iabp to successfully complete its self-test. this action will take less than 60 seconds to perform. in the event the iabp fails to successfully complete the self-test and exhibits electrical test failure code 58, affected users should remove the iabp from service and contact the manufacturer. a service representative will be replacing the defective solenoid driver boards. affected users having affected iabp unit(s) will be contacted by the manufacturer to schedule on-site service. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm563615.Htm https://www.Fda.Gov/safety/recalls/ucm563583.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Medical Device Safety Alert: Maquet System CS 100, CS100i and CS 300 Intra-Aortic Balloon Pumps
  • Manufacturer

Manufacturer