Description of Event or Problem · 0
REPORTABLE INFORMATION WAS DISCOVERED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 11-SEP-2025. ACCORDING TO A REPORT FROM CVS, THE PATIENT REPORTED A COMMUNICATION ISSUE WITH PUMP (B)(6) AND STATED THAT THEIR MEDICATION DEPLETED EARLY. THE PATIENT.DID NOT TROUBLESHOOT THE EARLY DEPLETION AND ADMITTED THAT IT WAS POSSIBLE THAT THE CASSETTE USED ON THE PUMP HAD BEEN OVERPRIMED. THE PATIENT FURTHER REPORTED THAT PUMP (B)(6) WOULD ALARM TO CHANGE THE BATTERY AND CASSETTE, AND TROUBLESHOOTING EFFORTS DID NOT RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED, AND IT IS UNKNOWN IF TROUBLESHOOTING WAS PERFORMED BY CVS. UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH REMUNITY PUMP (B)(6), CONFIRMED NO COMMUNICATION ATTENTION ALARMS. DURING THE INVESTIGATION, THE REMOTE AND PUMP WERE TESTED IN AN ANECHOIC CHAMBER FOR RADIO FREQUENCY (RF) POWER AND WERE FOUND TO BE WITHIN SPECIFICATION. NO SYSTEM ISSUES WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMMUNICATION ISSUES OR THE OBSERVED NO COMMUNICATION ALARMS. ADDITIONALLY, THE REMOTE LOGS CONFIRMED CASSETTE DEPLETED ALARMS, CONSISTENT WITH A PUMP-RELATED ISSUE. A TEST DELIVERY WAS ATTEMPTED DURING INVESTIGATION BUT ENDED EARLY WITH A CASSETTE PROBLEM ALARM. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF PAST FLUID INGRESS WAS OBSERVED THAT WOULD HAVE CONTRIBUTED TO THE CASSETTE DEPLETED ALARMS OBSERVED IN THE DEVICE LOGS AND THE CASSETTE PROBLEM ALARM OBSERVED DURING TESTING. THE CAUSE OF THE PAST FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH REMUNITY PUMP (B)6), REVEALED CASSETTE DEPLETED ALARMS, CONSISTENT WITH A PUMP-RELATED ISSUE. THESE ALARMS WOULD HAVE PROMPTED THE PATIENT TO REPLACE THE CASSETTE AND BATTERY FOR RESOLUTION. DURING THE INVESTIGATION, A TEST DELIVERY WAS ATTEMPTED BUT ENDED EARLY WITH A CASSETTE DEPLETED ALARM. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF PAST FLUID INGRESS WAS OBSERVED THAT WOULD HAVE CONTRIBUTED TO THE CASSETTE DEPLETED ALARMS OBSERVED IN THE LOGS AS WELL AS DURING TESTING. THE CAUSE OF THE PAST FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION, ALARMING ACCURATELY AND SUCCESSFULLY ENTERING A FAILSAFE STATE. ALTHOUGH NO PATIENT HARM WAS REPORTED BY CVS, THE RESULTS OF THE RETURNED PRODUCT INVESTIGATION COMPLETED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ARE BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.