BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAR-500

    MDR report key: 1010515 · Received February 11, 2008

    Report

    Report Number
    1010515
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 11, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE THE NXSTAGE MEDICAL, INC. CRRT MACHINE WAS RUNNING, THE FILTER DEVELOPED A CRACK OR SMALL HOLE AND STARTED SPRAYING BLOOD OUT OF THE FILTER. NO ALARMS ON THE MACHINE WENT OFF. THE NURSE WAS UNABLE TO RINSE THE BLOOD BACK TO THE PATIENT, AND HAD TO DISPOSE OF THE FILTER. THE FILTER WAS NEVER TOUCHED AND DEVELOPED THE LEAK ON ITS OWN. THE PHYSICIAN WAS NOTIFIED AND CBC WAS ORDERED. THE NURSE WHO WAS PRESENT RECORDED THE PATIENT'S NUMBERS WHEN THE EVENT OCCURRED. THE PATIENT NEEDED TWO UNITS OF PRBC'S AND TWO UNITS OF BLOOD PLATELETS AS A RESULT OF THIS EVENT. THE CRRT MACHINE OPERATED NORMALLY. THE FILTER AND THE TUBING WERE DISCARDED, SO CLINICAL ENGINEERING COULD NOT EXAMINE IT. NXSTAGE MEDICAL'S TECHNICAL SUPPORT WAS CALLED. THEY TOOK NOTES OVER THE PHONE AND SAID THEY WOULD REPORT THIS EVENT TO THE FDA. THEY SAID TO KEEP THE DEVICE INVOLVED IF THIS HAPPENS AGAIN. THE NURSING STAFF WAS INFORMED TO KEEP ALL DEVICES IN THE EVENT THIS OCCURS AGAIN. THESE FILTERS COME SIX IN A PACKAGE, SO THE INFORMATION ON THIS FILTER IS MOST LIKELY CATALOG NUMBER: CAR-500, LOT NUMBER 7127802, AND EXPIRATION DATE 05-2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAR-500 FILTER, CRRT KDI NXSTAGE MEDICAL, INC. CAR-500 7127802

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR