NRFIT, CASSETTE RESERVOIR 250ML

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE REPORTED ISSUE WAS DUPLICATED. THE ISSUE WAS TRACED TO A HOLE, FOUND ON THE SIDE OF THE CASSETTE BAG. HOWEVER, THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE FOR THIS CONDITION. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED.

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, AFTER LOADING THE DRUG SOLUTION, AIR WAS PULLED BUT NOT ALL THE AIR WAS REMOVED. REPORTER STATED THERE'S A POSSIBILITY THAT THE AIR MIGHT ENTER SOMEWHERE. THIS OCCURRED BEFORE PATIENT USE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.