BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 111222 · Received July 14, 1997

    Report

    Report Number
    111222
    Event Type
    Injury
    Date Received
    July 14, 1997
    Date of Event
    June 13, 1997
    Report Date
    June 19, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP RENAL
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING NIGHT TIME, DIALYSIS STAFF ON ROUTINE ROUNDS FOUND ALL SOLUTION INFUSED AND RUPTURE OF THE CATHETER ASSUMED TO BE CAUSED BY OVER PRESSURE. DUE TO A VIOLATION OF THE CLOSED CIRCUIT, ANTIBIOTIC THERAPY USING VANCOMYCIN WAS BEGAN. ADMIN VANCOMYCIN. SVS PERFORMED BY: COMPANY SVC TECH CHECKED PUMP OCCLUSION, A/D CONVERSION, CALIBRATED UPPER AND LOWER SCALE. CHECKED ALL VALVES DURING NORMAL OPERATION AND POWER FAILURE, FOUND NO PROBLEM. RAN 5 CYCLE WET TEST. MACHINE IS FUNCTIONING CORRECTLY. PUMP MUFFLER COVER IS BROKEN. THE HOSP SAID THEY WOULD REPALCE IT THEMSELVES. VALVES FAILED IN OPEN POSITION AND CAUSED LINE TO RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PERITONEAL DIALYSIS UNIT KPF BAXTER HEALTHCARE CORP RENAL 5C 4402 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention