Safety Alert Or Field Safety Notices for Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines

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.

Although the manufacturer has undertaken corrective actions to address some of the problems identified in the FSN, some ongoing checks are required when using the redesigned bloodlines.User checks for the following problems should be taken when using all models and manufacture dates of Novaline bloodlines:Problem
Risk
Action
Blood pump on the machine does not stop when blood reaches the venous extracorporeal blood circuit.
Blood loss
Operator to check that the blood pump stops when blood reaches the venous drip chamber. If the operator recognises that the pump may not stop, Operator should stop the blood pump manually and then connect the patient
Transducer protectors not connected properly
Air entrance into the circuit
Operator to check connections as per section 5.4 of IFU
Rare events of improper or incorrect fitting between arterial chamber and machine holders
Risk of air within the arterial chamber entering the bloodline circuit
Operator must check that the arterial chamber is placed at the right hole of the holder suiting its size and is properly fitted in