MDR event

Additional Manufacturer Narrative

THE PHOENIX OPERATOR'S MANUAL (REVISION A, SOFTWARE REVISION 3.34, DATED ON FEBRUARY, 2005) REPORTS THE FOLLOWING TWO WARNINGS: WARNING #01: "IMPROPER CONNECTIONS OF THE EXTRACORPOREAL CIRCUIT MAY CAUSE POTENTIAL PT SAFETY HAZARDS THAT MIGHT NOT BE DETECTED BY THE MACHINE: FOR INSTANCE, HEMOLYSIS CAUSED BY KINKS, CLAMPS OR OTHER RESTRICTIONS ON THE BLOOD LINE, BLOOD LOSS TO THE ENVIRONMENT/AIR INTO THE BLOOD CIRCUIT DUE TO LEAKAGE IN THE EXTRACORPOREAL CIRCUIT." (REFER TO INTRODUCTION, PAGE VIII AND SECTION 5 - DIALYSIS OPERATION, SUBPARAGRAPH 5.2 EXTRACORPOREAL CIRCUIT PREPARATION.) WARNING #02: "MONITORING OF THE VENOUS PRESSURE COULD NOT ALWAYS DETECT THE DISCONNECTION OF A VENOUS NEEDLE FROM ITS ACCESS SITE, WHICH MAY RESULT IN EXTRACORPOREAL BLOOD LOSS TO THE ENVIRONMENT. WHEN A VENOUS NEEDLE DISCONNECTS FROM ITS ACCESS, PRESSURE AT THE VENOUS MONITORING SIDE MAY ONLY DECREASE BY THE PRESSURE MAINTAINED WITHIN THE PT'S ACCESS SITE. THIS PRESSURE DROP MAY BE LESS THAN THE WIDTH OF THE MACHINE'S VENOUS PRESSURE ALARM WINDOW: IN THIS PARTICULAR CASE THE DISCONNECTION OF A VENOUS NEEDLE FROM ITS ACCESS SITE IS NOT DETECTABLE BY THE MACHINE, EVEN IF PRESSURE ALARMS AND ALARM WINDOWS ARE PROPERLY SET. TO REDUCE THE RISK OF NEEDLES DISCONNECTION, ENSURE THAT NEEDLES ARE FIRMLY SECURED TO THE ACCESS SITE AREA. MOREOVER, THE VENOUS PRESSURE ALARM LOWER LIMIT SHOULD BE SET AS CLOSELY AS PRACTICAL TO THE ACTUAL VALUE WITHOUT GENERATING EXCESSIVE NUISANCE ALARM." (REFER TO INTRODUCTION, PAGE XXXIII AND SECTION 9 - SPECS, SUBPARAGRAPH 9.2.7 - DETECTION OF EXTRACORPOREAL BLOOD LOSS.) IN 2005, GAMBRO DASCO MADE A HUMAN FACTORS EVAL STUDY. THE PURPOSE OF "HUMAN FACTORS" STUDY IS TO GET A DEEPER UNDERSTANDING FOR THE VENOUS NEEDLE DISLODGEMENT ISSUE FROM AN END USER PERSPECTIVE. IN PARTICULAR THE STUDY ANALYZE: (I) THE EVENTUAL NEED OF IMPROVEMENTS ON EXISTING WARNING ON THE OPERATOR'S MANUAL AND (II) THE NEED O ADDITIONAL MORE USER FRIENDLY TRAINING MATERIAL. FOLLOWING THIS HUMAN FACTOR STUDY, A LAMINATED CARD WARNING THE USER ON THE RISK OF NEEDLE DISLODGMENT AND INSTRUCTING HIM ON HOW TO PREVENT THIS EVENT. THIS LAMINATED CARD IS PART OF A SVC PACK WHICH WILL BE DISTRIBUTED TO EACH COUNTRY WHERE PHOENIX MACHINE ARE INSTALLED. GAMBRO CLINICAL INVESTIGATION HAS FOUND NO EVIDENCE TO SUGGEST THAT THE PHOENIX MACHINE MALFUNCTIONED DURING THE REPORTED EVENT. THIS EVENT IS BEING REPORTED UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY.