It was reported that during patient treatment with a prismaflex hf1400 set, the arterial luer lock connector had broke off, and was stuck inside the y-connector that was connected to normal saline.
This resulted in air entering the patient.
The patient presented with shortness of breath and was placed on a ventilator to relieve the symptoms.
The patient has recovered with no lasting effects and is now being treated with ordinary dialysis.
No additional information is available.
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Additional information: the actual device was received for evaluation.
Visual inspection revealed that the cone of the male luer connector of the access line was broken inside the priming accessory (y-line).
The y-connector, which is intended for use during priming only, was not removed from the hf1400 set when connecting the patient to the prismaflex system.
Per the prismaflex hf1400 instruction for use, ifu, the operator should "use the set by following the detailed on-line instructions provided by the prismaflex control unit".
After completion of the priming procedure, the prismaflex graphical user interface clearly states: "disconnect access line from y-line, connect to red luer lock on catheter (or other blood access)", i.
E.
The y-connector is not to be connected between the access line and the catheter.
Leaving the y-connector connected during patient treatment is considered user error.
The reported condition was verified.
The cause of the condition was not determined.
A nonconformance has been opened to address this issue.
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.
Should additional relevant information become available, a supplemental report will be submitted.
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