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Additional Manufacturer Narrative

GAMBRO CLINICAL ASSIST SVC (CAS) SPOKE WITH THE FACILITY'S NURSE MGR REGARDING VENOUS NEEDLE DISLODGEMENT. SHE WAS REMINDED THAT THE PHOENIX MACHINE WILL ONLY ALARM IF THERE IS A SIGNIFICANT CHANGE IN ANY OF THE PRESSURES. SHE REITERATED THAT NO DIALYSIS MACHINE CAN SUCCESSFULLY DETECT VENOUS NEEDLE DISLODGEMENT ESPECIALLY IF THE PT'S ACCESS IS COVERED AND THE NEEDLE BECOMES WEDGED IN ANOTHER OBJECT SUCH AS A PILLOW OR BLANKET. FURTHERMORE, IT IS COMMON PRACTICE TO KEEP THE PT'S ACCESS UNCOVERED AT ALL TIMES DURING A DIALYSIS TREATMENT TO AVOID THE POTENTIAL FOR NEEDLE DISLODGEMENT. GAMBRO LITERATURE WAS SENT TO HER ON THE SUBJECT OF PREVENTING NEEDLE DISLODGEMENT IN THE DIALYSIS UNIT. SHE HAS SINCE REEDUCATED HER STAFF ON THE IMPORTANCE OF KEEPING A PT'S ACCESS SITE UNCOVERED AT ALL TIMES DURING A DIALYSIS TREATMENT. 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.) ON NOVEMBER 2005, GAMBRO DASCO MADE A HUMAN FACTORS EVALUATION STUDY. THE PURPOSE OF THE "HUMAN FACTORS" STUDY IS TO GET A DEEPER UNDERSTANDING FOR THE VENOUS NEEDLE DISLODGEMENT ISSUE FROM AN END USER PERSPECTIVE WITH RESPECT TO THE EXISTING WARNINGS ON THE OPERATOR'S MANUAL AND EVALUATE ANY MODIFICATION TO ENSURE OUR MESSAGE IS EFFECTIVELY COMMUNICATED TO THE USER, INCLUDING REVISED WARNINGS AND DEVELOPING "USER FRIENDLY" TRAINING MATERIAL. FOLLOWING THIS HUMAN FACTORS STUDY, A LAMINATED CARD WITH OPERATOR WARNING TO PREVENT VENOUS NEEDLE DISLODGEMENT IS GOING TO BE INTRODUCED. THIS LAMINATED CARD IS PART OF A SVC PACK WHICH WILL BE AVAILABLE IN THE FUTURE. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF RESPONSIBILITY FOR THE EVENT. THIS EVENT IS BEING REPORTED UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY.