BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA TPE SET

    MDR report key: 1890089 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00040
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    January 22, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAFETY: (B)(6) WAS WRITTEN TO SPECIFICALLY ADDRESS SPECTRA EXCHANGES FLUID IMBALANCE DUE TO INADVERTENT CLAMPING OR IN THIS CASE UNK OCCLUSION OF THE WASTE BAG LINE. 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. IT IS IMPERATIVE THAT THE OPERATOR CONTINUOUSLY MONITOR THE COBE SPECTRA SYSTEM AND THE DONOR AND/OR PT. THIS EVENT IS NOT DIRECTLY CONTROLLABLE BY SPECTRA MANUFACTURING OR BY SPECTRA DISPOSABLES ENGINEERING. FIELD DIAGNOSTIC/CORRECTION: PROCEDURE WAS COMPLETED ON (B)(6) 2010. NO CLINICAL CONSEQUENCES WITH THE PT, THEY WERE FINE, DID NOT EXPERIENCE ANY SYMPTOMS AND WERE NOT TREATED MEDICALLY FOR THE EXTRA 2000 MLS OF VOLUME THEY RECEIVED. NO PT INTERVENTION WAS REQUIRED OR REPORTED. INVESTIGATION: HISTORICALLY, WHEN A REMOVE LINE BECOMES OCCLUDED, IT RESULTS IN PULSING OF THE PLASMA LINE TO THE WASTE BAG (ABOVE THE PUMP CARTRIDGE). IT DOES NOT CAUSE THE MACHINE TO ALARM, DUE TO THE MACHINE STILL BELIEVING THAT IT WAS REMOVING PLASMA. A PRESSURE BUILD UP DOES NOT OCCUR DUE TO THE OPEN PATH BACK TO THE PT VIA THE PASSIVE RBC RETURN LINE. IT IS UNLIKELY THAT AN INHERENT MANUFACTURING DEFECT EXISTS IN THE TUBING SET AS APPROXIMATELY 2L WERE SUCCESSFULLY REMOVED DURING THE PROCEDURE INTO THE WASTE BAG. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE MOST LIKELY ROOT CAUSE FOR THIS EVENT FROM THE INFO AVAILABLE IS A SEVERE KINK IN THE PLASMA LINE TUBING BETWEEN THE CHANNEL AND THE WASTE BAG.

    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; CUSTOMER REPORTS FLUID BALANCE ISSUE. CUSTOMER STATES SPECTRA DISPLAY INDICATED 4539 ML REMOVED DURING TPE PROCEDURE, BUT STATES WASTE BAG CONTAINED ONLY APPROXIMATELY HALF OF THAT VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA TPE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 95000000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other