Description of Event or Problem · 1
RE: WHAT A DIFFERENCE A REVISED LABEL WOULD MAKE IN PREVENTING CONFUSION; FRESENIUS' REVISED OPTIFLUX HOLLOW FIBER DIALYZERS. I'M A LONG-TERM HEMODIALYSIS PT. SEVERAL MONTHS AGO, WITHOUT MY KNOWLEDGE OR CONSENT, MY DIALYSIS CENTER PLACED ME ON THE REVISED, CHEAPER F200NR DIALYZER. SUBSEQUENTLY, I DEVELOPED UNCHARACTERISTIC QUEASINESS, AND A NOTICEABLY DECREASED APPETITE. ONCE I BEGAN INVESTIGATING, I QUICKLY ASCERTAINED THAT MY DIALYZER HAS BEEN REVISED. UNFORTUNATELY, BECAUSE THE F200NR DIALYZER LABEL HASN'T CHANGED, IT'S DIFFICULT TO PERSUADE MY NEPHROLOGIST TO CHANGE MY DIALYZER. I'M HOPING THE FDA WILL INVESTIGATE WHETHER FRESENIUS MEDICAL CARE NORTH AMERICA IS REQUIRED TO CHANGE THE F200NR LABEL TO PREVENT CONFUSION THAT THE PROTOTYPE AND REVISED F200NR DIALYZER ARE IDENTICAL DEVICES. -PLEASE NOTE: IF I HADN'T KEPT THE 2004 FRESNIUS F200NR INSERT (FROM MY DIALYZER PACKAGE), WHICH I COMPARED WITH MY PRESENT DIALYZER PACKAGE F200NR INSERT, I NEVER WOULD HAVE HAD THE PROOF THAT THE 2007 F200NR DIALYZER HAS BEEN REVISED. I'D BE MOST GRATEFUL IF YOU COULD VERIFY IF FRESENIUS HAS COMPLIED WITH FDA REGULATIONS REGARDING RE-LABELING OF SUBSEQUENTIALLY EQUIVALENT MEDICAL DEVICES. DIFERENCES IN THE F200NR FROM 2004 TO NOW, NOW ULTRAFILTRATION COEFFICIENT 56, 62, PRIMING VOLUME BLOOD 113, 112, FLOW RESISTANCE BLOOD 39, 55, MEMBRANE MATERIAL. ADVANCED FRESNIUS POLYSULFONE FRESNIUS POLYSULFONE. PLEASE NOTE THAT THE MEMBRANE MATERIAL HAS BEEN CHANGED, ALTHOUGH THE F200NR LABEL REMAINS THE SAME, PROMOTING A MISCONCEPTION THAT THE REVISED F200NR DIALYZER HASN'T BEEN REVISED. I USED THE F200NR DIALYZER THREE TIMES A WEEK. HEMODIALYSIS TREATMENT IS ONGOING, UNTIL I GET A TRANSPLANT OR DIE.