BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL DIALYSIS ULTRA BAG

    MDR report key: 36534 · Received August 26, 1996

    Report

    Report Number
    36534
    Event Type
    Malfunction
    Date Received
    August 26, 1996
    Date of Event
    March 1, 1996
    Report Date
    August 23, 1996
    Manufacturer
    RENAL DIV. BAXTER HEALTHCARE COR.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NUMEROUS INCIDENTS OF LEAKING TUBING AND DRAINBAGS OF CO'S DISPOSABLE HOME PERITONEAL DIALYSIS SYSTEMS. ONGOING PROBLEM HAS BEEN DISCUSSED WITH CO. SOME PRODUCTS HAVE BEEN RETURNED. PROBLEM CONTINUES UNRESOLVED AND CONCERN FOR POTENTIAL ADVERSE EVENT SUCH AS PERITONITIS OR OTHER INFECTION REMAINS. ADD'L LOT NUMBERS C-326801, C-311-35, C-318352.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL DIALYSIS ULTRA BAG DISPOSABLE PERITONEAL DIALYSIS BAG KDJ RENAL DIV. BAXTER HEALTHCARE COR. * C-317438, H-C-318352, C-318352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA