BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRIT-LINE

    MDR report key: 2598354 · Received February 3, 2010

    Report

    Report Number
    1721979-2009-00001
    Event Type
    Other
    Date Received
    February 3, 2010
    Date of Event
    April 6, 2009
    Report Date
    April 14, 2009
    Manufacturer
    HEMA METRICS
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE LENS DEFECTS WERE SIMPLY BLEMISHES, OR SURFACE DEFECTS AND WERE READILY APPARENT UNDER THE MICROSCOPE. HOWEVER, AN ANOMALY WAS NOTED ON THE OUTER EDGE OF THE LENS. THE COLOR WAS SLIGHTLY DIFFERENT IN A SMALL AREA OF THE BODY NEAR THE EDGE OF THE LENS. THE MEASUREMENTS, WHEN COMPARED TO THE AVERAGE OF THE CHAMBERS FROM THE 6 LOTS, WERE SLIGHTLY LARGER INDICATING A POSSIBILITY OF AN IMPROPER WELD. THE MEASUREMENTS ARE NOTED ON THE ATTACHED SPREAD SHEET. PRESSURE TESTING PROVED NEGATIVE AS LEAK(S) WERE FOUND AS REPORTED. IT IS A NECESSITY TO SEND THE SUBJECT CHAMBER TO MEDICA FOR ROOT CAUSE ANALYSIS. HEMA METRICS PERSONNEL CAN ONLY NOTE THAT A LEAK OCCURRED DUE TO A FAULTY WELD. IT IS ABOVE AND BEYOND THE CAPABILITY OF HEMA METRICS PERSONNEL TO DETERMINE THE ROOT CAUSE OF THE BAD WELD. AN E-MAIL WAS SENT TO MEDICA REQUESTING THE SUBJECT ANALYSIS BE PERFORMED AT MEDICA AND REPORTED TO HEMA METRICS.

    Description of Event or Problem · 1

    BLOOD CHAMBER LEAK DURING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRIT-LINE CRIT LINE BLOOD CHAMBER KOC HEMA METRICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other