BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7946296

    MDR report key: 7946296 · Received October 9, 2018

    Report

    Report Number
    7946296
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 4, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BEDSIDE HEMODIALYSIS PROCEDURE WAS IN PROGRESS. PRISMA WAS ON HOLD. BLOOD NOTED OVER PATIENT'S RIGHT SIDE, AND DEPENDENTLY. PER REPORT NURSE, NOTED LEAK FROM CONNECTION SITE FROM SET TO PATIENT. STARTED PRISMA AGAIN, NOTED AREA OF LEAK TO BE AT THE CONNECTION FROM THE SET TO THE HEMODIALYSIS (HD) CATHETER FROM INSIDE THE BLUE CAP. PRISMA DISCONTINUED. DISCONNECTED SET AND FLUSHED HD CATHETER AND NOTED NO LEAKS AT EITHER PORT. BOTH PORTS OF HD CATHETER FLUSHED AND ASPIRATED WITHOUT DIFFICULTY. NO VISIBLE CRACKS OR DAMAGE NOTED ON THE BLUE MALE PORT OF THE SET. GAMBRO PRISMA WAS RESUMED WITH A NEW M100 SET AND NO LEAKS NOTED FROM CONNECTION SITE OR HD CATHETER. H&H (HEMOGLOBIN AND HEMATOCRIT) DRAWN AT TIME AND REPORTED TO MD. HBG (HEMOGLOBIN) DROPPED AND 1 UNIT PRBC (PACKED RED BLOOD CELLS) ORDERED FOR TRANSFUSION.

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Other