BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 35024 · Received July 30, 1996

    Report

    Report Number
    35024
    Event Type
    Injury
    Date Received
    July 30, 1996
    Date of Event
    July 15, 1996
    Report Date
    July 30, 1996
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRE DIALYSIS WT 74.6; POST WT 75.2 KG. DRY WT 72 KG. MACHINE SET TO REMOVE 3 KG. PT SEEN IN ED 7/16 WITHOUT FL OVERLOAD, CHEST PAIN, DIAPHORESIS, ETC. TRANSFERRED PER AIR AMBULANCE FOR ULTRAFILTRATION. EQUIPMENT CHECKED AND FAILED ULTRAFILTRATION TEST. 2ND CHECK IT PASSED, MONITOR SAYS FLUIDS REMOVED; SCALE DOES NOT SUPPORT THIS. BIOMED FOUND THAT THE ULTRAFILTRATION PUMP DID NOT WORK DUE TO FAILURE OF A THERMAL PROTECTION FUSE ON THE PUMP. REPAIRED, RECALIBRATED. EVENT HAPPENED THE NEXT DAY ON ANOTHER PT; INCREASED WT, EDEMA. PT PRESENTED TO EMERGENCY WITH RALES, HYPERTENSION, FLUID OVERLOAD R/O EARLY PNEUMONIA/SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM 3 KIDNEY DIALYSIS MACHINE FII CGH MEDICAL, INC. C3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization