POLYFLUX LR CAPILLARY DIALYZER

Description of Event or Problem

THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.

Additional Manufacturer Narrative

INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. NO SAMPLE IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.