PRISMAFLO II

Additional Manufacturer Narrative

BASED ON THE INVESTIGATION IS THAT THE HEATING WIRE OF THE HEATING PROFILE WAS INTERNALLY DAMAGED DUE TO EXTERNAL MECHANICAL STRESS ADDITIONALLY THE HEATING PROFILE HAD CONTACT TO PATIENT'S THIGH. THERE IS ALSO A STRONG DOUBT IF THE CLEANING AND DISINFECTING METHODS (ONLY WITH ALCOHOL-BASED DISINFECTANT AGENTS OR READY-TO-USE DISINFECTANTS) FOR THE HEATING PROFILE WERE FOLLOWED CORRECTLY (ACCORDING THE INSTRUCTIONS FOR USE). THE COMBINATION OF THESE FACTORS MUST HAVE LEAD TO THE LOCAL OVERHEATING OF THE HEATING PROFILE AND CONSEQUENTLY TO THE BURN. THE BURN MARK WAS CLASSIFIED AS SECOND DEGREE BURN AND IS NOT JUDGED AS SERIOUS INJURY. BECAUSE OF THE CHARACTERISTICS OF THIS EVENT THE MANUFACTURER JUDGES THAT THIS EVENT FITS IN THE RECALL OF THIS PRODUCT THAT ADDRESSES THE POTENTIAL FAILURE. AS SOON AS THE HEALTHCARE PROVIDER RESPONDS TO THE "URGENT MEDICAL DEVICE CORRECTION" FORM FROM STIHLER ELECTRONIC THE AFFECTED HEATING PROFILES WILL BE REPLACED.

Description of Event or Problem

IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A BLOOD WARMER PRISMAFLO II. HEATING PROFILE OVERHEATED AND CAUSED BLISTERING BURNS ON THE PATIENT'S THIGH. TREATMENT WAS DISCONTINUED. PATIENT BURN WAS TREATED IN ACCORDANCE WITH HOSPITAL PROTOCOL.