HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER .. REG. ANVISA: 10068390123. 의 안전성 경고
Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 BAXTER HOSPITALAR LTDA 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.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
데이터 추가 비고
Attached to the communication letter to be sent by Baxter Ltda to its customers, will follow a response form that must be completed as soon as possible and sent to the company. ### The company announces the closure of the field action of updating the software of the machines through the file 824688 / 09-2, 10/29/2009.
원인
During a filling cycle, if the system is shut down or power failure occurs, the homechoice system may not register up to the last four pump drives infused into the patient when the power is reestablished. such a situation may lead to unregistered application of 15 to 60 ml of the fluid being infused into the patient.
조치
The company Baxter Hospitalar Ltda will be providing an updated version of the equipment software and has already begun to contact its customers through communication letters. The Technovigilance Unit is following the case.