BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALFAPUMP SYSTEM

    MDR report key: 25132011 · Received May 9, 2026

    Report

    Report Number
    3010817031-2026-00008
    Event Type
    Injury
    Date Received
    May 9, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SEQUANA MEDICAL NV
    Product Code
    SDQ
    PMA / PMN Number
    P230044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    OPENED BLADDER CATHETER INCISION. CUT ABOUT 1.5CM FROM EDGE OF CUFF ON PUMP SIDE. REMOVED OLD CUFF AND PIGTAIL INTACT. USED NEEDLE AND DILATORS TO ENTER BLADDER AT PRIOR ACCESS SITE. CONFIRMATION OF BLADDER WITH CONTRAST. REPLACEMENT BLADDER CATHETER PREPPED BY CUTTING SAME DISTANCE FROM CUFF. TITANIUM CONNECTOR TO ATTACH, STITCHES TO SECURE. STITCH THROUGH CUFF TO SECURE TO FASCIA. PLACEMENT FLURO CONFIRMED. ZOSYN IV GIVEN. 50G ALBUMIN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339096 ALFAPUMP SYSTEM ALFAPUMP SYSTEM SDQ SEQUANA MEDICAL NV BLADDER CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization