NRFIT EXTENSION SET W/ FILTER

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT A CHEMICAL LEAK OCCURRED AT THE BASE OF THE FILTER AND LINE CONNECTION ON THE PUMP SIDE LINE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

Additional Manufacturer Narrative

D3 - MFG ESTABLISHMENT NAME-CORRECTED. ONE DEVICE WAS RETURNED FOR ANALYSIS. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE LOOSE TUBING CONNECTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.