BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALFAPUMP

    MDR report key: 25316004 · Received May 28, 2026

    Report

    Report Number
    25316004
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 20, 2026
    Manufacturer
    SEQUANA MEDICAL NV, GHENT, ZWEIGNIEDERLASSUNG ZÜRI
    Product Code
    SDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE ALFA PUMP IS A NEWLY FDA-APPROVED IMPLANTED DEVICE FOR REMOVAL OF REFRACTORY ASCITES. HOWEVER, THERE WERE REPORTS OF MULTIPLE SHOCKS TO THE PATIENT SUCH THAT THE PATIENT HAD SHOCKING SENSATIONS LIKE INVOLUNTARY SPASMS, AS WELL AS PROGRESSIVELY INCREASING ERYTHEMA AT AN ABDOMINAL WALL SITE WITH MARKED PRURITUS AND HYPERSENSITIVITY TO TOUCH, DISCOMFORT SIGNIFICANT ENOUGH THAT HE SOMETIMES SITS WITH HIS SHIRT OFF AND REMAINS UNABLE TO SLEEP ON HIS RIGHT SIDE, BLADDER SHOCKS ASSOCIATED WITH HEART FLUTTERING AND BLADDER SPASMING WHICH IS WORSE WHEN RECLINING OR LYING FLAT, SHOCKS OCCURRING WHILE THE PUMP IS ON AND WHEN IN CERTAIN POSITIONS, TWO SHOCKS DURING AN APPOINTMENT WHICH 'NEARLY JOLTED HIM OUT OF THE EXAM CHAIR', ELECTRICAL TYPE SHOCKS OCCURRING WHILE PUMP IS ON AND WHEN IN CERTAIN POSITIONS. THE SHOCKS ARE DESCRIBED AS "INCREDIBLY PAINFUL EPISODES." THE DEVICE WAS IMPLANTED ON [REDACTED]. THE PATIENT HAD INTERMITTENT SHOCKING ALLEGEDLY FROM THE PUMP FROM [REDACTED]-POST-OP DAY 1 TO [REDACTED]-POST-OP DAY 47 WHEN THE PUMP WAS TURNED OFF DUE TO THE SHOCKING. ON [REDACTED]-58 DAYS LATER, THE PUMP WAS REMOVED DUE TO NO MORE ASCITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132414 ALFAPUMP ALFAPUMP SYSTEM SDQ SEQUANA MEDICAL NV, GHENT, ZWEIGNIEDERLASSUNG ZÜRI

    Patients

    Seq Age Sex Outcome Treatment
    1