AQUABPLUS, B2, HF 2500 KIT

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THE SHORT BLUE INLET TUBE CONNECTED TO THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RUPTURED DURING HEAT DISINFECTION. THE WATER FROM THE RUPTURED INLET TUBE SPRAYED A WALL OUTLET AND THE FIRE DEPARTMENT WAS DISPATCHED TO ADDRESS THE ISSUE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE BIOMED STATED THAT THE PRESSURE PROVIDED BY THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RUPTURED THE INLET TUBE. THE BIOMED STATED THE WATER FROM THE RUPTURED TUBE SPRAYED A WALL OUTLET LOCATED ON THE TREATMENT FLOOR, CAUSING THE WALL OUTLET TO SPARK AND SMOKE. THE SMOKE FROM THE WALL OUTLET TRIGGERED THE FACILITY SMOKE DETECTORS AND THE LOCAL FIRE DEPARTMENT WAS DISPATCHED TO EXTINGUISH THE SMOKE. THE BIOMED STATED THAT THE EVENT OCCURRED OUTSIDE OF CLINIC HOURS. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED CONFIRMED THAT NO THERMAL DAMAGE WAS IDENTIFIED WITHIN THE RO SYSTEM. THE BIOMED STATED THAT A FRESENIUS TECHNICIAN CAME ONSITE TO EVALUATE THE MACHINE. THE RUPTURED INLET TUBE WAS REPLACED AND THE PRESSURES WERE ADJUSTED TO RESOLVE THE INITIAL ISSUE. AN ELECTRICIAN WAS ALSO CALLED ONSITE TO REPAIR THE WALL OUTLET. THE BIOMED STATED THAT THE RO SYSTEM AND WALL OUTLET HAVE BEEN RETURNED TO FULL OPERATION. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: DURING THE INVESTIGATION OF THE AVAILABLE DATA, NO RISK OR HARM FROM THE AQUABPLUS WAS IDENTIFIED. THE ALLEGATION THAT THE BURST/RUPTURED BLUE TUBE WAS CAUSED BY AQUABPLUS HIGH PRESSURE COULD NOT BE CONFIRMED. THE MENTIONED BLUE DAMAGED TUBE IS PART OF THE 2008T DIALYSIS MACHINE AND IS NOT PART OF THE AQUABPLUS (AND NOT A VIVONIC PRODUCT). ALL PRESSURIZED COMPONENTS USED IN THE REVERSE OSMOSIS SYSTEMS ARE DESIGNED TO WITHSTAND 2.5 TIMES THE PRESSURE EXPECTED UNDER REGULAR OPERATION. FOR THIS REASON, ALL PRESSURIZED COMPONENTS ARE DESIGNED FOR A MAXIMUM LOAD OF 15BAR. THE HIGH WATER PRESSURE ISSUE IS INDICATED FROM THE INTAKE INFORMATION AND MACHINE FILES PROVIDED TO THE MANUFACTURER FOR REVIEW. THE HIGH WATER PRESSURE ISSUE WAS LIKELY CAUSED BY THE SETTINGS OF PRESSURES P-C/STAGE 1 AND P-CS/STAGE 2 AS WELL AS THE SETTING OF THE RING MAIN RETURN VALVE VR94. THE RING MAIN RETURN VALVE VR94 WAS FULLY CLOSED, WHICH CAUSES HIGH COUNTER PRESSURE IN THE RING MAIN. NO FEEDBACK WAS RECEIVED ABOUT THE RING PRESSURE AT THE LAST SUPPLY PORT AND THE SETTING OF VR94. IT IS RECOMMENDED TO OPEN THE VALVE VR94 TO REDUCE THE COUNTER PRESSURE IN THE RING MAIN. FURTHERMORE, IT IS RECOMMENDED TO INCREASE THE P-C AND DECREASE P-CS. STAGE 1 P-C SHOULD BE 1 BAR HIGHER THAN STAGE 2 P-CS.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THE SHORT BLUE INLET TUBE CONNECTED TO THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RUPTURED DURING HEAT DISINFECTION. THE WATER FROM THE RUPTURED INLET TUBE SPRAYED A WALL OUTLET AND THE FIRE DEPARTMENT WAS DISPATCHED TO ADDRESS THE ISSUE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE BIOMED STATED THAT THE PRESSURE PROVIDED BY THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RUPTURED THE INLET TUBE. THE BIOMED STATED THE WATER FROM THE RUPTURED TUBE SPRAYED A WALL OUTLET LOCATED ON THE TREATMENT FLOOR, CAUSING THE WALL OUTLET TO SPARK AND SMOKE. THE SMOKE FROM THE WALL OUTLET TRIGGERED THE FACILITY SMOKE DETECTORS AND THE LOCAL FIRE DEPARTMENT WAS DISPATCHED TO EXTINGUISH THE SMOKE. THE BIOMED STATED THAT THE EVENT OCCURRED OUTSIDE OF CLINIC HOURS. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED CONFIRMED THAT NO THERMAL DAMAGE WAS IDENTIFIED WITHIN THE RO SYSTEM. THE BIOMED STATED THAT A FRESENIUS TECHNICIAN CAME ONSITE TO EVALUATE THE MACHINE. THE RUPTURED INLET TUBE WAS REPLACED AND THE PRESSURES WERE ADJUSTED TO RESOLVE THE INITIAL ISSUE. AN ELECTRICIAN WAS ALSO CALLED ONSITE TO REPAIR THE WALL OUTLET. THE BIOMED STATED THAT THE RO SYSTEM AND WALL OUTLET HAVE BEEN RETURNED TO FULL OPERATION. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.