AQUADEX SYSTEM
Received Mar 21, 2014 · Event occurred Feb 19, 2014
Report 3003504604-2014-00002 · MDR key 3693192
Device
Generic name
Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
Manufacturer
Gambro Uf SolutionsModel number
A1100Lot number
880
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Hemolysis
Narrative
Additional Manufacturer Narrative
THE A1100 CONSOLE HAS NOT BEEN RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD INVESTIGATION HAS DETERMINED THAT THE A1100 CONSOLE MEETS SPECIFICATION AND THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE DEVICE. A DEVICE HISTORY RECORD INVESTIGATION HAS DETERMINED THAT THE A1650 CIRCUIT MEETS SPECIFICATION. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.
Description of Event or Problem
A PATIENT WAS DIAGNOSED WITH HEMOLYSIS SEVERAL HOURS AFTER INITIATING ULTRAFILTRATION THERAPY. THE PATIENT WAS ANTICOAGULATED AND HAD AN ACUTE ONSET OF REDDISH BROWN URINE. THE THERAPY WAS DISCONTINUED AND THE PATIENT¿S SYMPTOMS RESOLVED THE SAME DAY. THE CAUSE OF THE HEMOLYSIS IS UNKNOWN.
Additional Manufacturer Narrative
THE COMPANY COMPLETED THE TECHNICAL INVESTIGATION ON THE CONSOLE AND CIRCUIT. THE CONSOLE TECHNICAL INVESTIGATION CONCLUDED THAT THERE WAS NO PRODUCT MALFUNCTION. THE DEVICE CONTINUES TO MEET ITS PERFORMANCE SPECIFICATIONS AND PERFORMS AS INTENDED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS DEVICE S/N. THE VISUAL INSPECTION WAS COMPLETED ON THE RETURNED CIRCUIT AND FOUND NO ANOMALIES. THE CIRCUIT DEVICE HISTORY REVIEW FOUND THAT THE PRODUCT MEETS SPECIFICATION. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS PRODUCT LOT NUMBER.