Description of Event or Problem · 0
THE PATIENT HAS BEEN A HOME PERITONEAL DIALYSIS PATIENT FOR ABOUT THREE YEARS. (B)(6) CENTER CHANGED MACHINE VENDOR/EQUIPMENT FOR PERITONEAL DIALYSIS. WE UNDERWENT TRAINING ON THE BAXTER HOMECHOICE CLARIA ON (B)(6) 2024. SEVEN DAYS LATER, THE PATIENT WAS HOSPITALIZED AND REQUIRED EMERGENCY INTUBATION FOR FLUID OVERLOAD. DUE TO THE FAMILY'S HIGH SUSPICION THE PERITONEAL DIALYSIS CYCLER HAD MALFUNCTIONED, A REQUEST WAS MADE FOR A NEW MACHINE. A SECOND BAXTER HOMECHOICE, CLARIA, WAS SENT AFTER HOSPITAL DISCHARGE. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AND REQUIRED EMERGENCY INTUBATION THE FOLLOWING DAY FOR FLUID OVERLOAD. THE MOST NOTICEABLE CLINICAL ALARM IN BOTH INCIDENTS WAS "INCREASED INTRAPERITONEAL VOLUME," WHICH IS "OVERFILLING OR NOT DRAINING ENOUGH," WHICH RESULTED IN EXCESS FLUID IN THE ABDOMEN. IN ESSENCE, THE MACHINE FAILED TO PERFORM PERITONEAL DIALYSIS, COLLECTING & HOLDING FLUID IN THE PERITONEAL SPACE, RESULTING IN HOSPITALIZATIONS AND INTUBATIONS. (B)(6) CENTER SUPPOSEDLY MONITORED THE PATIENT AND THE DEVICE USING A WEB-BASED CONNECTIVITY PLATFORM CALLED SHARESOURCE. USING A MODEM, THE DEVICE CONNECTED WITH A WEB-BASED CONNECTIVITY PLATFORM THAT TRANSFERRED TREATMENT INFORMATION TO (B)(6) TO HELP THE NEPHROLOGIST OR NURSE MONITOR THE PATIENT'S THERAPY. (B)(6) FAILED TO MONITOR AND INVESTIGATE THEIR EQUIPMENT AND CLINICAL ALARMS, RESULTING IN TWO UNEXPECTED, FIRST-TIME, CONSECUTIVE HOSPITALIZATIONS RELATED TO PERITONEAL DIALYSIS. BOTH MACHINES WERE RETURNED, AND THEIR SERIAL NUMBERS WERE PHOTOGRAPHED FOR OUR DOCUMENTATION. GIVEN THE DANGEROUS NATURE OF THIS MACHINE AND THE NEAR-DEATH EXPERIENCES, WE TRANSITIONED TO HEMODIALYSIS. THE HOMECHOICE CLARIA APD IS A DANGEROUS MEDICAL DEVICE. REFERENCE REPORT: MW5159470.