BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3973648 · Received August 1, 2014

    Report

    Report Number
    1722028-2014-00288
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER CONTACTED TERUMO BCT SUPPORT SPECIALIST FOR TROUBLESHOOTING WHEN THEY NOTICED THE WASTE BAG WAS EMPTY. DURING TROUBLESHOOT,THE CUSTOMER STATED THAT THE PLASMA LINE WAS 'POPPING'. THEY STOPPED THE CENTRIFUGE AND CHECKED LOADING TO SEE IF PLASMA CAME UP THE PLASMA LINE. LITTLE PLASMA CAME UP THE PLASMA LINE. THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. THE SET WAS VISUALLY INSPECTED FOR KINKS, MISASSEMBLY, MISSING PARTS, OCCLUSIONS AND OTHER DEFECTS WHICH MAY HAVE CONTRIBUTED TO THE ISSUE, NONE WERE FOUND. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. THE PATIENT WAS STABLE AFTER THE SECOND PROCEDURE. THE MEDICAL DIRECTOR RECOMMENDED AN ADJUSTMENT OF TPE VOLUME TO ACCOUNT FOR VOLUME OF EXCHANGE THAT WAS NOT COLLECTING PLASMA. THE FINAL NET APHERESIS FLUID BALANCE WAS +223ML = 4215 ML VOLUME IN - 2992 ML VOLUME OUT, PERTHE RUN SHEETS. ROOT CAUSE: THE DISPOSABLE SET WAS ANALYZED AND NO ANOMALIES WERE FOUND. BASED ON THE CUSTOMER'S DESCRIPTION OF THE PLASMA LINE PULSING, THE PLASMA WAS LIKELY NOT BEING COLLECTED DUE TO AN AIR BLOCK. THE CAUSE FOR THE AIR BLOCK IS INCONCLUSIVE. IT IS POSSIBLE THAT THE KIT WAS STILL NOT LOADED CORRECTLY AFTER RESETTING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PLASMA WAS NOT COLLECTING IN THE WASTE BAG DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE. PER THE CUSTOMER, THEY HAD GIVEN A BAG OF FRESH FROZEN PLASMA (FFP) FOR REPLACEMENT FLUID, BUT HADN'T COLLECTED ANYTHING IN THE WASTE BAG. THE CUSTOMER PERFORMED RINSEBACK AND ENDED THE PROCEDURE. A SECOND PROCEDURE WAS SET UP AND STARTED WITH NO ISSUES. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY HAS OCCURRED.

    Description of Event or Problem · 1

    THE PATIENT'S FULL IDENTIFICATION NUMBER IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449947 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA TPE SET GKT TERUMO BCT 04W15299

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Other