MEDEX FILTER

Description of Event or Problem

IT WAS REPORTED THAT A BROWN DISCOLORATION WAS SEEN WITHIN THE FILTER WHILE IN USE WHEN PN WAS ADMINISTERED TO A PATIENT. FRESENIUS CUSTOM MADE TPN COMMENCED AT 17.00 DISCOLORED FILTER AT 22.00PM. NO OTHER SIGNS OF DEFECT. DISCOLORATION ONLY TO THE FILTER AND NO LEAKAGE FOUND IN SET UP. NO PATIENT INJURY.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. TWO SAMPLES RECEIVED FOR INVESTIGATION. DURING INVESTIGATION THE INITIAL VISUAL INSPECTION CONFIRMED THAT PRODUCTS WERE ASSEMBLED AS PER DRAWING SPECIFICATION AND THE SAMPLES DO NOT SHOW ANY SIGNS OF DAMAGE. MECHANICAL TEST PERFORMED WITH NO ISSUE FOUND - ALL PARTS CONNECTIONS ARE BONDED PROPERLY. SAMPLE RELATED TO (B)(6) THE SAMPLE HAS A VERY LIGHT COLORED FILTER ((B)(6)) TO LIGHT BROWN. THERE ARE ALSO LOOSE FIBERS INSIDE THE FILTER. THE OTHER PARTS OF THE SAMPLE ARE FREE OF DEFECTS. SAMPLE RELATED TO (B)(6) THE SAMPLE HAS A LIGHT COLORED FILTER ((B)(6)) TO LIGHT BROWN. THE OTHER PARTS OF THE SAMPLE ARE FREE OF DEFECTS. BASED ON THE INVESTIGATION RESULTS WE CAN CONFIRM REPORTED ISSUE BUT WE CAN NOT DETERMINE ROOT CAUSE OF THIS ISSUE. THE DISCOLORATION OF THE FILTER MAY BE CAUSED BY A COMBINATION OF MEDICINES GIVEN TO THE PATIENT AS AN INFUSION. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. NO TREND OF CONFIRMED CUSTOMER COMPLAINTS RELATED TO THIS ISSUE WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. NO SCAR, NCR AND NO DISPOSITION OF NONCONFORMING MATERIAL/PARTS WERE PROCESSED WITHIN THIS WORK ORDER CONNECTED WITH STATED ISSUE.