AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT AN AQUABPLUS 1500 WAS INTERMITTENTLY EXPERIENCING A T1-TEST FAILURE AND DISPLAYING A MESSAGE STATING PUMP P1S WAS DEFECTIVE. THE REVERSE OSMOSIS (RO) GAVE OFF AN AUDIBLE ALARM AND DISPLAYED ALARM CODE ¿F-04-51-04¿. THE BIOMED REPORTED THAT IT ONLY HAPPENED WHEN THEY MANUALLY STARTED THE T1-TEST. THE ALARM DOES NOT OCCUR WHEN THE RO AUTOMATICALLY STARTS THE T1-TEST. THE BIOMED ALSO REPORTED FINDING THERMAL DAMAGE ON THE RO. IT WAS REPORTED THAT THE THERMAL OVERLOAD SWITCH ON THE STAGE 2 PUMP WAS TRIPPING. THE BIOMED WAS ABLE TO TEMPORARILY RESOLVE THIS ISSUE BY RESETTING THE THERMAL OVERLOAD SWITCH. THE BIOMED REPORTED SEEING SIGNS OF HEAT ON THE BACK OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) AND THE CABLE TO THE CONTACTOR. THE BIOMED WAS REQUESTING PART NUMBERS FOR THE MEMBRANES FROM TECHNICAL SUPPORT. THE BIOMED WAS ADVISED TO CHANGE THE MPS AND THE CABLE. UPON FOLLOW-UP, THE BIOMED REPORTED THAT THERMAL DAMAGE WAS FOUND AT BOTH THE STAGE 1 AND STAGE 2 MOTOR PROTECTION SWITCHES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED STATED THE FAILURE OCCURRED IN THE MORNING, PRIOR TO THE START OF ANY PATIENT TREATMENTS. THE BIOMED WAS ABLE TO FIX THE RO BY REPLACING THE MPS AND CONNECTED CABLES IN BOTH STAGES. THE BIOMED SAID THE STAGE 1 SWITCH TRIPPED FIRST, SO THEY CHANGED TO STAGE 2 PUMP. WHEN THE BIOMED TRIED USING STAGE 2, THEY HEARD A POP AND SAW SPARKS. NO BURNING SMELL WAS OBSERVED. UPON EVALUATION OF THE SWITCHES, THE BIOMED IDENTIFIED BURN DAMAGE ON ONE OF THE CONNECTORS ON EACH. THE BIOMED SAID THAT ONLY ONE CONNECTOR FROM EACH STAGE WAS IMPACTED, BUT IT WAS THE SAME ONE ON BOTH. THE BIOMED CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY AND THERE WERE NO KNOWN LOCAL POWER GRID ISSUES AROUND THE EVENT DATE. THE BIOMED DID NOT HAVE THE MACHINE FILES AND REPORTEDLY DID NOT KNOW HOW TO DOWNLOAD THEM. THE BIOMED WAS UNSURE IF PHOTOS WERE AVAILABLE FOR REVIEW. THE BIOMED AGREED TO PROVIDE THEM IF THEY FOUND ANY. NO SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF SIMILAR COMPLAINTS WAS NOT REQUIRED. THE REPORTED EVENT CAN BE CONFIRMED BASED ON THE PROVIDED INFORMATION. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED, AND A REVIEW OF THE MACHINE FILES WAS NOT NECESSARY. THE REPORTED EVENT CAN BE ATTRIBUTED TO A CAPA PROJECT. THE THERMAL DAMAGE WAS LIKELY CAUSED BY BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH (MPS). INCREASED CONTACT RESISTANCE LIKELY LED TO A RISE IN THERMAL ENERGY AT THE CONTACT POINTS. WHEN THIS HAPPENS THE CABLE LUGS/WIRING AT THE MPS BECOME OVERHEATED, WHICH LEADS TO DISCOLORATION/DAMAGE AT THE BAD ELECTRICAL CONTACT POINT. THIS CAN CAUSE THE THERMAL OVERLOAD SWITCH OR THE MPS (DEPENDING ON THE OPERATION MODE) TO TRIP. THE REPORT THAT THE ERROR CODE OCCURS ONLY IF THE AQUABPLUS IS STARTED MANUALLY IS NOT PLAUSIBLE. THE REPORTED ERROR CODE APPEARS RANDOMLY AND DOES NOT DEPEND ON A MANUAL OR AUTOMATIC START OF THE SYSTEM. IT WAS ALSO NOTED THAT THE PART NUMBER REQUEST FOR THE MEMBRANES IS NOT RELATED TO THE REPORTED FAILURE PATTERN OF THERMAL DAMAGE. THE THERMAL DAMAGE FAILURE PATTERN IS A KNOWN ISSUE AND A CAPA WAS OPENED TO ADDRESS IT. AS A CORRECTIVE ACTION FROM THE CAPA PROJECT, A NEW DESIGN OF THE MPS AND ITS WIRING WAS DEVELOPED AND RELEASED. HOWEVER, THE AFFECTED AQUABPLUS IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION BEING IMPLEMENTED. FURTHERMORE, THE NEW DESIGN IS CURRENTLY NOT AVAILABLE ON THE US MARKET. BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED.

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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT AN AQUABPLUS 1500 WAS INTERMITTENTLY EXPERIENCING A T1-TEST FAILURE AND DISPLAYING A MESSAGE STATING PUMP P1S WAS DEFECTIVE. THE REVERSE OSMOSIS (RO) GAVE OFF AN AUDIBLE ALARM AND DISPLAYED ALARM CODE ¿F-04-51-04¿. THE BIOMED REPORTED THAT IT ONLY HAPPENED WHEN THEY MANUALLY STARTED THE T1-TEST. THE ALARM DOES NOT OCCUR WHEN THE RO AUTOMATICALLY STARTS THE T1-TEST. THE BIOMED ALSO REPORTED FINDING THERMAL DAMAGE ON THE RO. IT WAS REPORTED THAT THE THERMAL OVERLOAD SWITCH ON THE STAGE 2 PUMP WAS TRIPPING. THE BIOMED WAS ABLE TO TEMPORARILY RESOLVE THIS ISSUE BY RESETTING THE THERMAL OVERLOAD SWITCH. THE BIOMED REPORTED SEEING SIGNS OF HEAT ON THE BACK OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) AND THE CABLE TO THE CONTACTOR. THE BIOMED WAS REQUESTING PART NUMBERS FOR THE MEMBRANES FROM TECHNICAL SUPPORT. THE BIOMED WAS ADVISED TO CHANGE THE MPS AND THE CABLE. UPON FOLLOW-UP, THE BIOMED REPORTED THAT THERMAL DAMAGE WAS FOUND AT BOTH THE STAGE 1 AND STAGE 2 MOTOR PROTECTION SWITCHES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED STATED THE FAILURE OCCURRED IN THE MORNING, PRIOR TO THE START OF ANY PATIENT TREATMENTS. THE BIOMED WAS ABLE TO FIX THE RO BY REPLACING THE MPS AND CONNECTED CABLES IN BOTH STAGES. THE BIOMED SAID THE STAGE 1 SWITCH TRIPPED FIRST, SO THEY CHANGED TO STAGE 2 PUMP. WHEN THE BIOMED TRIED USING STAGE 2, THEY HEARD A POP AND SAW SPARKS. NO BURNING SMELL WAS OBSERVED. UPON EVALUATION OF THE SWITCHES, THE BIOMED IDENTIFIED BURN DAMAGE ON ONE OF THE CONNECTORS ON EACH. THE BIOMED SAID THAT ONLY ONE CONNECTOR FROM EACH STAGE WAS IMPACTED, BUT IT WAS THE SAME ONE ON BOTH. THE BIOMED CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY AND THERE WERE NO KNOWN LOCAL POWER GRID ISSUES AROUND THE EVENT DATE. THE BIOMED DID NOT HAVE THE MACHINE FILES AND REPORTEDLY DID NOT KNOW HOW TO DOWNLOAD THEM. THE BIOMED WAS UNSURE IF PHOTOS WERE AVAILABLE FOR REVIEW. THE BIOMED AGREED TO PROVIDE THEM IF THEY FOUND ANY. NO SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION.