BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 2210077 · Received August 1, 2011

    Report

    Report Number
    1722028-2011-00252
    Event Type
    Other
    Date Received
    August 1, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K103090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN PROGRESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING ALL RED IN THE CHANNEL DURING A THERAPEUTIC PLASMA EXCHANGE, BUT COULD NOT DETERMINE WHY. A 'RBCS DETECTED IN PLASMA LINE' ALARMED AND THE CUSTOMER DISABLED THE DETECTOR. THE CUSTOMER STATED THAT THE ALBUMIN FOR THE PROCEDURE HAD BEEN DILUTED FROM 25% TO 5% WITH STERILE WATER. THE PROCEDURE WAS IMMEDIATELY ABORTED WITHOUT RINSEBACK AND THE PHYSICIAN NOTIFIED. A CHEM PANEL WAS DRAWN AND PAIN MEDICATION WAS GIVEN TO THE PT. THE PT CONDITION HAD RETURNED TO HIS BASELINE PRIOR TO THE PROCEDURE. THE CUSTOMER IS NOT ALLEGING A DEFICIENCY WITH EITHER THE OPTIA OR THE DISPOSABLE. THE DISPOSABLE IS NOT BEING RETURNED AS THE CUSTOMER DID NOT FEEL IT WAS NECESSARY IN THIS SITUATION. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY FROM HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA EXCHANGE SET SEPARATOR, AUTOMATED BLOOD CELL AND P1 LKN CARIDIANBCT 05T3217

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other