Device Recall Baxter Auto Syringe AS50 Infusion Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    31992
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0159-06
  • 사례 시작날짜
    2005-05-06
  • 사례 출판 날짜
    2005-11-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-06-23
  • 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
    A 'check flange' alarm may occur even though the syringe has been properly loaded into the as50 infusion pump. the false alarm may occur during the syringe loading process or while an infusion is running. also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
  • 조치
    Urgent Device Correction letters dated 5/5/05 were sent to the AS50 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the false 'Check Flange' alarms due to a combination of certain syringe clamp assemblies on a specific serial numner range of pumps and the dimensional attributes of the Monoject 35 cc syringes. The accounts were requested to check the serial numbers on their AS50 pumps against the listing of serial numbers in the letter and contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process to screen and replace the syringe clamp assemblies. The accounts were also informed of the delay in the detection of a downstream occlusion when the AS50 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize infusion sets with thick-walled, small bore tubing to minimize the detection time; and * Always verify that the clamping device or stopcock is open in the fluid path prior to starting an infusion. The accounts were requested to complete and fax back the enclosed reply form indicating that they have examined their inventory for AS50 pumps, and listed the affected serial numbers found to be returned to Baxter for correction. Baxter extended the recall on 1/24/06 to 43 customers who received the pumps after the "check Flange Alarm" issue had been corrected in production, but had not been notified of the "Delay in Detection of Downstream Occlusion" issue. Copies of the Operator's Manual Addendum addressing the delay issue were included with the letter. Baxter also sent copies of the Operator's Manual Addendum to all of the accounts who received the 5/5/05 le

Device

  • 모델명 / 제조번호(시리얼번호)
    serial numbers 12040401AB through 12040420AB, serial number 12050501AB and above, and those pumps that had syringe clamp assembly AAS5001503RP replaced on refurbished or serviced AS50 pumps since 5/14/02.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide including Puerto Rico, and internationally to Colombia, Chile, Brazil, Saudi Arabia and Canada.
  • 제품 설명
    Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA