BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 19659232 · Received July 2, 2024

    Report

    Report Number
    3016798778-2024-00035
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 2, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 03-JUN-2024 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 04-JUN-2024. THE PATIENT REPORTED THAT WHEN THEY WOKE UP, THEIR REMOTE WAS NOT COMMUNICATING WITH THE PUMP AND TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT DID NOT REPORT THAT THEY ATTEMPTED TO USE THEIR BACKUP PUMP. THE PATIENT WENT TO THE ER TO RECEIVE IV REMODULIN. FROM THE ER, THE PATIENT REPORTED HAVING A COLD AND FEELING A LITTLE MORE SHORT OF BREATH THAN NORMAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER REPORTED BEING PALE AND HAVING BLUE LIPS. THE PATIENT WAS SUBSEQUENTLY RESTARTED ON REMUNITY THERAPY AND DISCHARGED FROM THE HOSPITAL. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED 02-JUL-2024 (REPORT NUMBER 3016798778-2024-00035). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT.DURING INVESTIGATION, BOTH RETURNED SYSTEMS CONNECTED WITHOUT ISSUE INDICATING SUCCESSFUL COMMUNICATION BETWEEN PAIRED PUMPS AND REMOTES. THE RF POWER OF BOTH PAIRS OF PUMPS AND REMOTES WERE TESTED AND ALL WERE WITHIN SPECIFICATION. LOGS FROM REMOTE UTRM0012912 (PAIRED WITH PUMP UTPM0016510) SHOW THAT DELIVERY WAS STARTED ON THE DATE OF THE COMPLAINT AND THIS SYSTEM WAS USED FOR ~26 HOURS UNTIL THE DELIVERY WAS STOPPED BY THE USER. THE SYSTEM GENERATED NO ALARMS DURING THE TIMEFRAME OF THE COMPLAINT. THE SYSTEM FUNCTIONED WITHIN SPECIFICATION AND NO FURTHER INVESTIGATION WAS PERFORMED.LOGS FROM REMOTE UTRM0012913 (PAIRED WITH PUMP UTPM0016521) SHOW THAT THE PUMP GENERATED A NO COMMUNICATION ATTENTION ALARM ON THE DATE OF THE COMPLAINT. THE USER WAS ABLE TO SWITCH TO THE BACKUP SYSTEM AND CONTINUE THEIR THERAPY. DURING INVESTIGATION, PUMP UTPM0016521 WAS DISASSEMBLED, AND EVIDENCE OF MINOR FLUID INGRESS WAS OBSERVED. THE ALARM WAS ATTRIBUTED TO THE FLUID INGRESS. A TEST DELIVERY WAS INITIATED AND RAN FOR THE LENGTH OF A FULL DELIVERY WITH NO ALARMS GENERATED. NO CASSETTES WERE RETURNED AND NO FURTHER INVESTIGATION IS POSSIBLE. THE SYSTEM FUNCTIONED WITHIN SPECIFICATION AS IT ALARMED FOR NO COMMUNICATION 10 HOURS AFTER THE PUMP STOPPED COMMUNICATING WITH THE REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684187 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization ADEMPAS| ADEMPAS| BREZTRI AEROSPHERE| BREZTRI AEROSPHERE| CALCIUM| CALCIUM| DIGOXIN| DIGOXIN| FUROSEMIDE| FUROSEMIDE| LEVOTHYROXINE SODIUM| LEVOTHYROXINE SODIUM| LIOTHYRONINE SODIUM| LIOTHYRONINE SODIUM| MONTELUKAST SOD TABS| MONTELUKAST SOD TABS| OMEPRAZOLE| OMEPRAZOLE| POTASSIUM CHLORIDE| POTASSIUM CHLORIDE| PROAIR HFA| PROAIR HFA| SPIRONOLACTONE-HCTZ| SPIRONOLACTONE-HCTZ| ZYRTEC| ZYRTEC