BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI MX

    MDR report key: 25008063 · Received April 27, 2026

    Report

    Report Number
    3004548776-2026-00191
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 11, 2026
    Report Date
    April 27, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: WHILE CHECKING THE 24-HOUR INFUSIONS, IT WAS NOTED THAT THE DOXORUBICIN INFUSION HAD 10 ML REMAINING AND WAS NEARING COMPLETION: AT APPROXIMATELY 8:20 A.M., AT WHICH TIME IT FINISHED. THE INFUSION WAS SCHEDULED TO END AT 10:40 A.M.; THE PHARMACIST ON DUTY WAS NOTIFIED. THE SHIFT LOG INDICATED THAT A FRESENIUS PUMP HAD BEEN REPLACED THE PREVIOUS NIGHT BECAUSE THE INFUSION HAD RUN DRY ON SEVERAL OCCASIONS. MEDICAL HISTORY: ON (B)(6) 2026 AT 8:00 AM, I VISITED THE PATIENT IN WARD 116. THE PATIENT WAS CONSCIOUS, ALERT, ORIENTED, AND AFEBRILE. DA-EPOCH PROTOCOL: CYCLE 5, DAY 2. AFTER PRIOR SKIN ASEPSIS AND ANTISEPSIS USING STERILE TECHNIQUE, AN IMPLANTABLE CATHETER WAS INSERTED INTO THE RIGHT HEMITHORAX USING A 20G X 0.75 SURECAN NEEDLE; VENOUS RETURN WAS OBTAINED AND SALINE SOLUTION FLOWED WITHOUT DIFFICULTY; A 3-WAY STOPCOCK WAS PLACED; THE SITE WAS COVERED WITH A TEGADERM 8. 5X10, AND THE EQUIPMENT IS CONNECTED FOR THE XL PHOTOSENSITIVE INFUSION PUMP AND, VIA CHANNEL B, THE MACRO-DRIP SET, AS WELL AS THE FRESENIUS PHOTOSENSITIVE INFUSION PUMP. PREMEDICATION IS INITIATED WITH: ONDANSETRON 16 MG IN 100 ML OF 0.9% SALINE SOLUTION - PREDNISONE 100 MG PO. (B)(6) 2026 11:11 10+40 A PUSH-STOP TECHNIQUE IS PERFORMED ON THE PERMEABLE IMPLANTABLE CATHETER; VENOUS RETURN IS CONFIRMED. 24-HOUR INFUSIONS ARE INITIATED AS FOLLOWS: 1. DOXORUBICIN 18.1 MG IN 500 ML OF 0.9% SALINE AT 20.8 ML/H VIA A PHOTOSENSITIVE FRESENIUS PUMP. SIMILARLY, VINCRISTINE 0.72 MG IS ADMINISTERED IN 500 ML OF 0. 9% AT A RATE OF 20.8 CC/H VIA A PHOTOSENSITIVE XL PUMP; FINALLY, VIA A MACRO-DRIP PUMP IN A CONCOMITANT Y-LINE INFUSION, ETOPOSIDE 90 MG IN 400 CC OF 0.9% SALINE AT 16.7 CC/H. PATIENT TOLERATING TREATMENT: THE DEPARTMENT IS NOTIFIED. (B)(6) 2026: 8:00 AM I VISIT THE PATIENT IN UNIT 116; THE PATIENT IS CONSCIOUS, ALERT, ORIENTED, AND AFEBRILE. THE PATIENT HAS NO FAMILY MEMBERS PRESENT; I INTRODUCE MYSELF AND EXPLAIN THE TREATMENT TO BE INITIATED. DA-EPOCH PROTOCOL, CYCLE 5, DAY 3. PREDNISONE 100 MG PO IS ADMINISTERED. UPON CHECKING THE 24-HOUR INFUSIONS, IT WAS NOTED THAT THE DOXORUBICIN MEDICATION HAD A REMAINING VOLUME OF 10 ML AND WAS NEARLY FINISHED: APPROXIMATELY AT 8:20 A.M., AT WHICH TIME IT CONCLUDED. THE INFUSION WAS SCHEDULED TO END AT 10:40 A.M. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303119 AGILIA VP MC WIFI MX INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z019732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown