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 FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL MANAGER AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM EXPERIENCED ONGOING ISSUES WITH REGENERATION FLOW WITH THE WATER SOFTENER TANK AND CHEMICAL DISINFECTION. THE FST RESOLVED THE WATER PRE-TREATMENT SOFTENER ISSUE BY EMPTYING ALL CONTENTS OF THE MEDIA TANK AND REPLACING IT WITH NEW UNDERBED GRAVEL AND SOFTENER RESIN. THE RO STAGE 1 MEMBRANES WERE ALSO REPLACED. THERMAL DECOMPOSITION WAS ALSO IDENTIFIED DURING THE EVALUATION ON THE POWER CORD AT THE MOTOR PROTECTION SWITCH (MPS) CONNECTION IN STAGE 1 AND STAGE 2. THE POWER CORD IN STAGE 1 AND STAGE 2 WERE ORDERED AND REPLACED TO RESOLVE THE REPORTED ISSUE. THE MPS IN BOTH STAGE 1 AND STAGE 2 WERE ALSO REPLACED AS A PRECAUTION. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER CONFIRMED THE REPORTED ISSUE WITH THE PROVIDED PHOTOGRAPH AND INTAKE INFORMATION. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED WHICH LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND BECAME DISCOLORED/DAMAGED FROM THE RELEASED THERMAL ENERGY. A MAINS LINE ALSO COULD HAVE BEEN MISSING (AS A RESULT OF THE BAD ELECTRICAL CONTACT) AND THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH (DEPENDING ON THE OPERATION MODE) WAS LOADED UNBALANCED AND COULD HAVE TRIPPED, RESULTING IN THE INTERRUPTION OF DEVICE OPERATION AND SUBSEQUENT ERROR CODES/T1 TEST FAILURES. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING WAS DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR PROTECTION SWITCH AND WIRING IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL MANAGER AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM EXPERIENCED ONGOING ISSUES WITH REGENERATION FLOW WITH THE WATER SOFTENER TANK AND CHEMICAL DISINFECTION. THE FST RESOLVED THE WATER PRE-TREATMENT SOFTENER ISSUE BY EMPTYING ALL CONTENTS OF THE MEDIA TANK AND REPLACING IT WITH NEW UNDERBED GRAVEL AND SOFTENER RESIN. THE RO STAGE 1 MEMBRANES WERE ALSO REPLACED. THERMAL DECOMPOSITION WAS ALSO IDENTIFIED DURING THE EVALUATION ON THE POWER CORD AT THE MOTOR PROTECTION SWITCH (MPS) CONNECTION IN STAGE 1 AND STAGE 2. THE POWER CORD IN STAGE 1 AND STAGE 2 WERE ORDERED AND REPLACED TO RESOLVE THE REPORTED ISSUE. THE MPS IN BOTH STAGE 1 AND STAGE 2 WERE ALSO REPLACED AS A PRECAUTION. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.