BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA TPE TUBING SET

    MDR report key: 1890845 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00029
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    March 12, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FLUID BALANCE WAS SET AT 100% AND THE REPLACEMENT FLUID WAS ALBUMIN. THE OPERATOR INITIALLY HAD DIFFICULTY LOADING THE PLASMA LINE. ADJUSTMENTS WERE MADE TO MINIMIZE KINKS AND TWISTS. NUMEROUS ALARMS FOR "PLASMA LIEN CONTAMINATION DETECTED" TOWARDS THE BEGINNING OF THE PROCEDURE. THE OPERATOR SAW AIR BUBBLES SPORADICALLY PASSING THROUGH THE TUBING AT THE CCM. ABOUT 3/4 OF THE WAY THROUGH THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PT EXPRESSED THAT HER CHEST FELT AS IF IT WERE FILLING WITH FLUID AND THAT SHE COULD NOT CATCH HER BREATH. THE PROCEDURE WAS STOPPED. THE MACHINE INDICATED THAT THERE SHOULD BE 3700 OR 3750ML IN THE PLASMA WASTE BAG, BUT IT APPEARED THAT THERE WAS ONLY ABOUT 1000ML IN THAT BAG. A KINK WAS NOTICED IN THE PLASMA (COLLECT) TUBING JUST BELOW THE CCM. THE CUSTOMER DID NOT BELIEVE THAT A CHECK-OUT OF THE COBE SPECTRA MACHINE WAS NECESSARY. THEY EXPRESSED THAT THEY THOUGHT THE KINK IN THE DISPOSABLE MAY HAVE CONTRIBUTED TO THE INCIDENT. NO MEDICAL INTERVENTIONS TO TREAT THE HYPERVOLEMIA IN THE PATIENT WERE REPORTED. POST-PROCEDURE, THE PATIENT'S CONDITION WAS STABLE AND SHE WAS ALERT. ROOT CAUSE: THIS 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. IT IS UNCONFIRMED WHETHER A BLOCKAGE WAS PRODUCED BY A MFG DEFECT OF THE COBE SPECTRA DISPOSABLE OR BY THE WAY THE DISPOSABLE WAS LOADED AND HANDLED AT THE CUSTOMER SITE.

    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. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE. DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE USING A COBE SPECTRA MACHINE AND A COBE SPECTRA DISPOSABLE, THE OPERATOR REPORTED A DISCREPANCY BETWEEN THE PLASMA VOLUME COLLECTED AND THE VOLUME DISPLAYED BY THE COBE SPECTRA MACHINE. THE PT WAS STABLE AND ALERT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA TPE TUBING SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLATELET LKN CARIDIANBCT 950000000 01S15221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention