BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 24581840 · Received March 11, 2026

    Report

    Report Number
    MW5185132
    Event Type
    Injury
    Date Received
    March 11, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MEDICA S.P.A.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT, WHO HAD UNDERGONE INTERVENTIONAL THERAPY FOR CEREBRAL INFARCTION, WAS ADMITTED TO THE DEPARTMENT ON (B)(6) DUE TO 'CHEST TIGHTNESS AND SHORTNESS OF BREATH FOR 1 YEAR, WITH RECURRENCE AND WORSENING OVER THE PAST 10 DAYS. DUE TO MULTIPLE ORGAN DYSFUNCTION SYNDROME, SIGNIFICANT CHEST TIGHTNESS AND SHORTNESS OF BREATH, OLIGURIA, AND SEVERE INTERNAL ENVIRONMENT DISORDERS, CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED. DURING THE TREATMENT PERIOD FROM (B)(6), THE MACHINE INTERMITTENTLY TRIGGERED ALARMS INDICATING THE PRESENCE OF AIR IN THE VENOUS TUBING. DESPITE REPEATED TROUBLESHOOTING, THE ALARMS PERSISTED, PROMPTING A CHANGE OF EQUIPMENT TO CONTINUE THE THERAPY. THERE WAS NO INTERVENTION. THERE WAS NO REPORTED PATIENT OUTCOME. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637784 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MEDICA S.P.A. 26401420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown