BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 1890824 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00022
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    October 28, 2009
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPERATOR STOPPED THE PROCEDURE AND CLAMPED THE LINE TO THE PT, SO NO AIR WAS RETURNED TO THE PATIENT. THE PT IS FINE. THE DISPOSABLE SET WAS RETURNED ALONG WITH AN ATTACHED ASTOTUBE DISPOSABLE BLOOD WARMER ACCESSORY AND THE SALINE BAG ATTACHED TO THE GREEN SOLUTION SPIKE. A MFG MISASSEMBLY WAS IMMEDIATELY APPARENT. THE PLASMA REMOVAL LINE LEADING TO THE WASTE BAG WAS BONDED TO THE CASSETTE IN THE PLASMA RECIRCULATION LINE BOND SOCKET LOCATION AND THE RECIRCULATION LINE WAS BONDED TO THE REMOVE LINE BOND SOCKET LOCATION. THIS MFG ERROR IS MUTUALLY EXCLUSIVE OF THE PRESENCE OF AIR IN THE RETURN LINE. THE DEVICE OPERATOR WAS ASKED DURING SUBSEQUENT FOLLOW-UP, IF THEY HAD A SALINE DRIP GOING DURING THE TIME THEY HAD ALL OF THE ALARMS AND THEY REPLIED AFFIRMATIVELY THAT THEY DID. THE OPERATOR WAS ASKED WHETHER THEY CLAMPED THE SALINE LINE WHEN THEY WERE INSTRUCTED TO PARTIALLY EMPTY THE SALINE LINE WHEN THEY WERE INSTRUCTED TO PARTIALLY EMPTY THE SALINE DRIP CHAMBER AFTER PRIME AND THE CUSTOMER RESPONDED THAT THEY HAD NOT. IF THE OPERATOR DOES NOT CLOSE THE ROLLER CLAMP ON THE SALINE LINE PRIOR TO INVERTING THE SALINE BAG TO SQUEEZE THE DRIP CHAMBER (CLEARING IT OF SALINE) AND THEY RETURN THE BAG TO THE HANGING POSITION, AIR CAN BE TRAPPED IN THE LINE AND WILL TRAVEL TO THE BW TUBING. MFG RETRAINING WAS REQUESTED FOR PROPER ASSEMBLY OF THE PLASMA RECIRC / PLASMA REMOVE LINES. ALL OPERATORS HAD COMPLETED THIS TRAINING BY (B)(4) 2009. CARIDIANBCT WILL APPEND OPTIA PROCEDURAL TRAINING MATERIALS. SPECIFICALLY ADDING A SLIDE TO THE OPTIA OPERATOR ESSENTIALS TRAINING SLIDESHOW USED BY CARIDIANBCT INSTRUCTORS.

    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. DURING THE RUN, THE CUSTOMER REPORTED THAT SHORTLY INTO THE TPE PROCEDURE, THEY EXPERIENCED A NUMBER OF LOW AND HIGH LEVEL RESERVOIR SENSOR DETECTED EXCESS FLUID ALARMS AND THEN SHE HAD NOTICED AIR IN THE BLOOD WARMER (BW) LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED BLOOD CELL AND PL LKN CARIDIANBCT 08R3125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK