BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP

    MDR report key: 23390019 · Received October 27, 2025

    Report

    Report Number
    MW5177962
    Event Type
    Injury
    Date Received
    October 27, 2025
    Report Date
    October 21, 2025
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QJY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SQ REMUNITY SELF-FILL PT VIA REMUNITY PUMP. PT REPORTS CURRENTLY IN HOSPITAL DUE TO BLOOD CLOT IN LEG AND INFECTED SITE. PT WENT CHANGED SITE AND WHEN REMOVED IT LOOKED BAD SO WENT TO ER FOR CLOT AND INFECTION. UNKNOWN DATE PT PRESENTED TO HOSPITAL. PT RECEIVED 2 NEW PUMPS RECENTLY. PT KEEPS GETTING PUMP FAILURE ON NEW PUMP. PT ALSO HAD TO GO THROUGH 3 CARTRIDGES AND NEEDLES TO FILL PUMP. SERIAL NUMBER NOT PROVIDED. PT STARTED REMUNITY DEVICE IN (B)(6) 2023. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES, UPON RETURN. DID WE REPLACE THE DEVICE? PT RECEIVED 2 NEW PUMPS RECENTLY. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES 6. WHAT TROUBLESHOOTING WAS COMPLETED? SENDING EMAIL TO NCE TEAM TO CALL PT AND GO OVER PUMPS AGAIN SO THERE IS LESS WASTE. DID PT EXPERIENCE MISSED DOSES/INTERRUPTION IN THERAPY? NO. DIAGNOSIS FOR USE: PULMONARY ARTERIAL HYPERTENSION. PT CODE: 4595. DEVICE CODE: 2447. REF REPORT: MW5177963.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292386 REMUNITY PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization OPSUMIT.| REMODULIN.