ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6, H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER THREE HOURS OF STARTING THE DIALYSIS TREATMENT WITH ULTRAFILTER U9000; THE PATIENT EXPERIENCED FATIGUE, DISCOMFORT AND COLD SWEATING WITH CONVULSIONS. AN INFUSION OF 500ML NORMAL SALINE WITH OXYGEN INHALATION WERE ADMINISTERED. DIALYSIS TREATMENT WAS INTERRUPTED AND ELECTROCARDIOGRAM (ECG) MONITORING WAS INITIATED. THE PATIENT BLOOD PRESSURE DECREASED AND THE PULSE WAS ELEVATED. THE PATIENT'S BLOOD WAS RETURNED AND DIALYSIS TREATMENT WAS TERMINATED. THE PATIENT¿S BLOOD PRESSURE EVENTUALLY IMPROVED AND THE SWEATS DECREASED. IT WAS ADDITIONALLY REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE ULTRAFILTER. THE ULTRAFILTER WAS REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.