BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 19164035 · Received April 23, 2024

    Report

    Report Number
    3016798778-2024-00022
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 27, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    PMA / PMN Number
    K190182
    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 28-MAR-2024 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 29-MAR-2024. THE PATIENT REPORTED THEY WERE NOT SYMPTOMATIC, BUT THEY WERE GOING TO THE ER TO WAIT FOR COURIER DELIVERY OF NEW PUMPS IN CASE SUPPORTIVE CARE WAS NEEDED. A CLINICIAN REPORTED THE PATIENT'S PUMP WAS ALARMING TO DISCONNECT FROM CATHETER AND THEY WERE NOT ABLE TO PAIR THEIR BACK-UP PUMP WITH ITS REMOTE. NO COMPONENTS 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 23-APR-2024 (REPORT NUMBER 3016798778-2024-00022). 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. THE LOGS FROM REMOTES UTRM0013531 AND UTRM0013532 SHOW THAT PUMP UTPM0017295 WAS SUCCESSFULLY PAIRED TO UTRM0013531 TWICE AND UTRM0013532 ONCE, WHICH CONTRADICTS THE COMPLAINT INFORMATION STATING THAT PUMP UTPM0017295 WAS NEVER ABLE TO PAIR. DURING THE TIMEFRAME OF THE COMPLAINT, PAIRING LOST AND NO COMMUNICATION ATTENTION ALARMS WERE GENERATED ON BOTH REMOTES. THE LOGS FROM PUMPS UTPM0017294 AND UTPM0017295 SHOW THAT THEY WERE NOT POWERED ON WITHIN THE TIMEFRAME OF THE ATTENTION ALARMS, MEANING THAT THE ATTENTION ALARMS WERE GENERATED AS EXPECTED. THE RF POWER OF THE PUMPS AND REMOTES WAS TESTED USING AN ANECHOIC CHAMBER FIXTURE, AND ALL DEVICES WERE FOUND TO BE WITHIN SPECIFICATION. TEST DELIVERIES WERE RUN ON BOTH SYSTEMS. PUMP UTPM00017294 PERFORMED AS EXPECTED. PUMP UTPM0017295 GENERATED A CASSETTE DEPLETED ALARM WITHIN 10 MINUTES OF STARTING DELIVERY. THE PUMP WAS DISASSEMBLED FOR FURTHER INVESTIGATION AND FLUID INGRESS WAS OBSERVED TO BE THE CAUSE OF THE ALARM. NO CASSETTES WERE RETURNED, MEANING THE CAUSE OF THE FLUID INGRESS INTO THE PUMP CANNOT BE DETERMINED. NO FURTHER INVESTIGATION IS POSSIBLE. BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION AS THEY ENTERED A FAILSAFE STATE AFTER ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941914 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization ACETAMINOPHEN| ACETAMINOPHEN| ALBUTEROL SULFATE| ALBUTEROL SULFATE| BUMETANIDE| BUMETANIDE| BUSPIRONE HCL| BUSPIRONE HCL| DICLOFENAC SODIUM| DICLOFENAC SODIUM| ELIQUIS| ELIQUIS| FLUOXETINE HCL| FLUOXETINE HCL| OXYCODONE HCL| OXYCODONE HCL| OXYGEN| OXYGEN| PANTOPRAZOLE SODIUM| PANTOPRAZOLE SODIUM| PREGABALIN| PREGABALIN| SOD CHLORIDE| SOD CHLORIDE| TREPROSTINIL| TREPROSTINIL