PRISMAFLEX SETS (ST)

Description of Event or Problem

IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED NEAR THE FLUID OUTLET OF 13 PRISMAFLEX ST150 SET DRAIN BAGS DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE LEAKAGE "APPEARED SOMETIME AFTER THE START OF TREATMENT, AND SOME DIFFERENT TIMES DURING THERAPY IN EACH CASE." THE BAGS WERE REPLACED EACH TIME TO CONTINUE TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). PRISMAFLEX ST150 SET HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA (B)(4) TO DELIVER CRRT TO TREAT PATIENTS IN AN ACUTE CARE ENVIRONMENT DURING THE COVID-19 PANDEMIC. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.