CADD MEDICATION CASSETTES

Additional Manufacturer Narrative

B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT "THE CASSETTE WAS RETURNED FROM THE WARD WHEN THE RESIDUAL QUANTITY WAS NOT SUFFICIENT.¿ PER REPORTER, THERE WAS NO ALARM RECORDED. IT WAS CONFIRMED THAT THE ACCURACY WAS WITHIN 3%. THE EVENT OCCURRED DURING AN INFUSION AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H3: FOUR PICTURES WERE ATTACHED TO THE COMPLAINT. NO DISCREPANCY WAS DETECTED IN THE PHOTOS RECEIVED CONSIDERING THE FAILURE MODE REPORTED. THE REPORTED ISSUE WAS NOT CONFIRMED, AND THE ROOT CAUSE WAS NOT DETERMINED. IF THE SAMPLE IS RECEIVED, THE COMPLAINT WILL BE REOPENED.