ADSORBA 300

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3, H6 AND H10. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE FIRST PROVIDED PHOTO SHOWED THE POLYFLUX FILTER HAD TWO BLACK PARTICLES IN THE HEADER AREA. IT WAS NOT CLEARLY VISIBLE IF THE PARTICLES ORIGINATED FROM THE ADSORBA. THE REPORTED CONDITION WAS VERIFIED. VISUAL INSPECTION OF THE OTHER PHOTOGRAPH SHOWED THE ADSORBA FILTER WITH THE PRODUCT LABEL. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. AS THE ACTUAL DEVICE WAS NOT RETURNED, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CARBON LEAK WAS OBSERVED FROM AN ADSORBA 300C WHEN CONNECTED WITH A POLYFLUX 17L. THE EVENT HAPPENED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.