Description of Event or Problem · 0
AN INITIAL REPORT OF PATIENT HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS ON (B)(6) 2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2023. THE PATIENT REPORTED THAT ONE OF HIS PUMPS HAD LIQUID LEAK INTO THE BATTERY CHAMBER, AND THE BACK-UP PUMP WOULD NOT COMMUNICATE WITH THE REMOTE. PUMPS UTPM0009100 AND UTPM0009101 WERE RETURNED FOR INVESTIGATION ALONG WITH REMOTES UTRM0005699 AND UTRM0005700. LOGS FROM UTRM0005700/UTPM0009100 SHOW THAT THE SYSTEM GENERATED A TOTAL OF 12 PUMP FAILURE ALARMS FROM THE DAY PRIOR TO THE DATE OF THE COMPLAINT ONWARD. THE PUMP FAILURE ALARMS WERE RELATED TO THE TIMEKEEPING SYSTEM WITHIN THE PUMP, WHICH HAD LIKELY BEEN DAMAGED DUE TO INGRESS. THE PUMP WAS DISASSEMBLED TO INSPECT FOR INGRESS, AND SIGNIFICANT AMOUNTS OF REMODULIN RESIDUE WERE FOUND ON THE PCB, PARTICULARLY ON AND AROUND THE COMMAND PROCESSOR. THIS IS LIKELY THE CAUSE OF THE FAULTS, AND CAUSED SUBSEQUENTLY PERMANENT DAMAGE TO THE SYSTEM. NO CASSETTES WERE RETURNED, SO THE CAUSE OF THE LEAKS CANNOT BE DETERMINED. NO FURTHER INVESTIGATION IS POSSIBLE. UTRM0005700/UTPM0009100 FUNCTIONED AS EXPECTED BECAUSE IT GENERATED AN ALARM WHEN APPROPRIATE, AND ENTERED A FAILSAFE STATE. IT WAS NO LONGER FUNCTIONING AS EXPECTED DURING THE INVESTIGATION. UTRM0005699/UTPM0009101 FUNCTIONED AS EXPECTED BECAUSE THE SYSTEM GENERATED A NO COMMUNICATION ALARM 10 HOURS AFTER THE PUMP SHUTDOWN. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.