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
Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
조치
A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.