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
(1) under certain conditions, if a malfunction alarm occurs while the pump is in the "paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the preventive maintenance screen in service/biomed mode with a total delivery time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
조치
The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.