BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA THERAPEUTIC PLASMA EXCHANGE SET

    MDR report key: 1890096 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00045
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    July 22, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DISCUSSED APPROPRIATE TESTING FOR THIS DEVICE WITH THE OPERATOR INCLUDING PUMP OCCLUSION TESTS, PUMP SPEEDS, AND VALVE FUNCTION. HE HAS PERFORMED THESE TESTS AND FOUND NO PROBLEMS. HE HAS ALSO PERFORMED A PRIME WITH ALARMS TEST WITH NO PROBLEMS AND IS CURRENTLY RUNNING A SALINE RUN IN WHICH THE VOLUME APPEARS ACCURATE SO FAR. THE DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. IT IS LIKELY THAT THE ROOT CAUSE OF THIS INCIDENT IS RELATED TO AN OCCLUSION IN THE PLASMA COLLECT TUBING LINE THAT SELF-CORRECTED DURING THE PROCEDURE AS EVIDENCED BY SOME PLASMA WASTE BEING COLLECTED. IT IS UNCONFIRMED WHETHER THIS BLOCKAGE WAS PRODUCED BY A MFG DEFECT OF THE COBE SPECTRA DISPOSABLE OR BY THE WAY THE DISPOSABLE WAS LOADED OR HANDLED AT THE CUSTOMER SITE. AN INTERNAL HEALTH HAZARD ANALYSIS WAS PERFORMED TO ADDRESS HYPERVOLEMIA IN COBE SPECTRA EXCHANGE PROCEDURES DUE TO OCCLUSION OF THE PLASMA COLLECT LINE DUE TO CLAMPING NEAR THE WASTE BAG. THE ANALYSIS CONFIRMS THAT THIS FAILURE COULD RESULT IN MODERATE INJURY DUE TO HYPERVOLEMIA IN A TPE PROCEDURE PARTICULARLY IN THE CASE OF PTS WITH ORGAN DYSFUNCTION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. DISPLAYED PLASMA REMOVED WAS 3966 ML, BUT THE MEASURED VOLUME IN THE BAG WAS 1824 ML. THE NURSE WANTED TO KNOW WHY THEY WERE NO ALARMS. BECAUSE THE PT HAS KIDNEY FUNCTION, THE PHYSICIAN DECIDED TO GIVE LASIX TO HELP REMOVE THE EXCESS FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA THERAPEUTIC PLASMA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 04S15251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention