AQUABPLUS, HF 1500

Description of Event or Problem

A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) CALLED FRESENIUS TECHNICAL SUPPORT TO REPORT THAT 2008T HEMODIALYSIS (HD) MACHINE WOULD NOT CONNECT THE CRIT-LINE DURING POWER UP DUE TO A FAILED FUNCTION BOARD. DURING REPAIR, THE BMT FOUND A BURNED INTEGRATED CIRCUIT (IC) ON THE FUNCTION BOARD. UPON FOLLOW UP, THE BMT SAID THAT A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE FUNCTION BOARD WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED TO ANY OTHER COMPONENTS. THE MACHINE HOURS WERE UNKNOWN. IT IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE FUNCTION BOARD, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE FUNCTION BOARD WAS DISCARDED.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BY MEANS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE AN INADEQUATE DESIGN OF THE CABLE LUGS, WHICH RESULTED IN BAD ELECTRICAL CONTACTING AT THE CABLE/CABLE LUG ATTACHED TO THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE CONCERNED CABLE AND THE MOTOR PROTECTION SWITCH WERE REPLACED TO RESOLVE THE ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT NO ISSUES WITH THE WIRING/CABLE LUGS AND/OR THE MOTOR PROTECTION SWITCH WERE ENCOUNTERED DURING TESTING.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. MELTING DAMAGE WAS IDENTIFIED ON THE CABLE TO THE MOTOR PROTECTION CONNECTOR. ERROR "F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE" WAS RECEIVED. IT WAS INDICATED UPON INITIAL REPORTING THAT THE CABLE AND SWITCH WOULD BE REPLACED TO RESOLVE THE REPORTED ISSUE. UPON INITIAL FOLLOW-UP FROM FRESENIUS TECHNICAL SERVICES THE BIOMED REPORTED THAT THE ISSUE WAS RESOLVED. NO REPAIR DETAILS WERE PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WILL BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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