NRFIT, SET, ADMIN, SPIKE

Additional Manufacturer Narrative

E1: (B)(6). 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 AN INCIDENT OCCURRED DURING THE USE OF AN INFUSION SET FOR PCEA CADD PUMP. FOLLOWING THE ABSENCE OF AN INFUSION, THE DEVICE HAD TO BE CHANGED. DURING INSERTION, IT WAS IMPOSSIBLE TO PURGE THE TUBING, AS THE LIQUID WAS NOT ADVANCING. A SECOND TUBE WAS REQUESTED, AND THE SAME PROBLEM OCCURRED. THESE 2 TUBES WERE STORED CORRECTLY. THERE WERE NO FOLDS OR KINKS ON THE PACKAGING. IT WAS ONLY WITH A THIRD TUBE THAT IT WAS POSSIBLE TO PURGE. SINCE THE DATE OF THIS INCIDENT NO PURGING ANOMALY HAS OCCURRED. THERE HAVE BEEN NO CONSEQUENCES FOR THE PATIENT'S CARE.

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.

Additional Manufacturer Narrative

TWO ADMIN SETS WERE RETURNED FOR ANALYSIS OF COMPLAINT OF FAILURE MODE OCCLUDED/BLOCKAGE. AS RECEIVED NO DAMAGE OR ANOMALIES WERE OBSERVED. EACH ADMIN SET WAS ATTEMPTED TO BE PRIMED WITH 10 ML. BOTH SETS RETURNED AN OCCLUSION ALARM TEMPORARILY AND THEN CLEARED. THE ALARM THEN REPEATED. IN ATTEMPTS TO VISUALIZE A POTENTIAL OCCLUSION EACH SET WAS ATTACHED TO THE HYDROSTATIC PRESSURE PUMP. FLOW WAS SUCCESSFULLY ESTABLISHED THROUGH THE SET. IN ATTEMPTS TO REPLICATE CLINICAL USE EACH ADMIN SET WAS ATTACHED TO A PROVIDED BAG WITH RED DYE AND INSERTED INTO A CADD SOLIS PUMP. THE SET WAS ATTEMPTED TO BE PRIMED WITH 10 ML. NO ALARMS, LEAKAGE OR DIFFICULTIES PRIMING WERE OBSERVED. THE COMPLAINT OF NOT BEING ABLE TO PRIME CAN BE CONFIRMED DUE TO THE OBSERVED ALARM. THE PROBABLE CAUSE IS UNKNOWN.