Alerta De Seguridad O Notificaciones De Seguridad para GemStar infusion system

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.

The following pump faults may lead to over-infusion, low infusion rates or an interruption of infusion:occlusion detection problems, due to pressure sensor calibration drift;
pump failure without warning, due to leaking batteries;
voltage of lithium battery dropping below 2.4 volts, causing pump to cease functioning;
an error with the pump’s motor assembly potentially causing the motor to rotate backwards at flow rates of less than 2 ml/hr.The MHRA continues to investigate this and other recent Field Safety Corrective Actions implemented by Hospira.