Device Recall Medfusion Syringe Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    78922
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1134-2018
  • 사례 시작날짜
    2017-11-13
  • 사례 출판 날짜
    2018-03-05
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pump, infusion - Product Code FRN
  • 원인
    Certain medfusion syringe pump models, series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. the inability of a pump to recognize a syringe (i.E. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. misidentification of a syringe is where the pump misinterprets the syringe size.
  • 조치
    Consignees were notified via mail on 11/13/2017, 01/09/2018, and 02/12/2018, as a result of expansions of the recall and the need to provide additional instructions and information to consignees. Instructions in the first letter date 11/13/2017 instructed customers to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to utilize the enclosed Reference Tool when verifying syringe size, and to complete the return the Response Form. Instructions in the letter dated 01/09/2018 included to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to advise all clinicians overseeing use of the affected devices to utilize the enclosed Reference Tool, to remove the pump if the syringe is not recognized or is read as an incorrect size during programming or infusion, to notify impacted customers if the devices were further distributed, and to complete the return the Response Form. Instructions in the letters dated 02/12/2018 included to identify any affected devices on hand, complete and return the Urgent Medical Device Recall Response Form, and arrange for repair of the affected as per the location of the consignee in Canada or the USA. If the consignee is located in the USA, the three options include to return to Smiths Medical for repair, arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair, or arrange for onsite repair by Smiths Medical if there are more than 10 pumps onsite. If the consignee is located in Canada, the two options include to return to Smiths Medical for repair or arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair. Consignees not located in the USA or Canada were instructed to contact their Smiths Medical Representative to discuss repair options. For further questions, please send inquiries to SmithsMedical3033@stericycle.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Medfusion Syringe Pump 4000 Series || The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • 제조사 모회사 (2017)
  • Source
    USFDA