NRFIT CONNECTOR SET

Description of Event or Problem

IT WAS REPORTED THAT, WHEN THE PCEA IS CONNECTED, AN ALARM SOUNDS, WHICH IS THOUGHT TO BE DUE TO A BLOCKAGE. AFTER REPLACING IT WITH ANOTHER EXTENSION TUBE, THERE ARE NO PROBLEMS. THIS OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

E1: (B)(6). H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

ONE DEVICE WAS RETURNED FOR ANALYSIS. AS RECEIVED, NO DAMAGES OR ANOMALIES WERE OBSERVED. NO ERRORS OR ALARMS WERE OBSERVED, AND NO LEAKAGE WAS NOTED DURING TESTING AND ISSUE WAS NOT REPLICATED. THE COMPLAINT OF ALARMING WHEN CONNECTED COULD NOT BE REPLICATED OR CONFIRMED.