AQUABPLUS, B2, HF 2000 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

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE POWER CORD CONNECTION OF THE STAGE 1 MOTOR PROTECTION SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED DESCRIBED THE CONNECTION AS BLACK AND CHARRED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE MACHINE WAS INITIALLY EVALUATED AFTER THE ERROR F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE WAS RECEIVED DURING THE T1 TEST. THERE WERE NO BLOWN FUSES. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 1. UPON FOLLOW-UP WITH THE USER FACILITY BIOMED, IT WAS REPORTED THAT NO PARTS WERE REPLACED. THE INITIAL ISSUE WAS THE RESULT OF USER ERROR. THE STAGES OF THE RO SYSTEM WERE RESTARTED TO RESOLVE THE REPORTED ISSUE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS A RESUTL FO THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE PROVIDED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE COULD BE CONFIRMED BASED ON THE PROVIDED INFORMATION FROM THE CUSTOMER. THE REPORTED THERMAL DAMAGE IS MOST LIKELY CAUSED BY A COMBINATION OF LINE FLUCTUATIONS AND A BAD ELECTRICAL CONTACT AT THE PINS OF THE MOTOR PROTECTION SWITCH, WHICH CAUSES TRANSITION RESISTANCE AND INCREASED TEMPERATURE/THERMAL ENERGY AT THE CONTACT PINS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED. HOWEVER THE REDESIGNED PART IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, NO PART HAS BEEN REPLACED. UNTIL THE NEW DESIGN BECOMES AVAILABLE IT IS ADVISED THAT THE BLADE RECEPTACLES AND WIRING BE REPLACED IN STAGE 1.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE POWER CORD CONNECTION OF THE STAGE 1 MOTOR PROTECTION SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED DESCRIBED THE CONNECTION AS BLACK AND CHARRED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE MACHINE WAS INITIALLY EVALUATED AFTER THE ERROR F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE WAS RECEIVED DURING THE T1 TEST. THERE WERE NO BLOWN FUSES. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 1. UPON FOLLOW-UP WITH THE USER FACILITY BIOMED, IT WAS REPORTED THAT NO PARTS WERE REPLACED. THE INITIAL ISSUE WAS THE RESULT OF USER ERROR. THE STAGES OF THE RO SYSTEM WERE RESTARTED TO RESOLVE THE REPORTED ISSUE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS A RESULT FO THE REPORTED ISSUE.