BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4316571 · Received December 4, 2014

    Report

    Report Number
    2523595-2014-00312
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C326 WAS PERFORMED. THERE WERE NO NONCONFORMANCES RELATED TO THIS COMPLAINT. THIS LOT MET RELEASE REQUIREMENTS. A REVIEW OF LOT C326 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM #17: RETURN PRESSURE, ALARM #1: AIR DETECTED, EQUIPMENT PERFORMANCE, AND FEELING ABNORMAL. NO TRENDS WERE DETECTED. CAPA (B)(4) WAS INITIATED FOR ALARM #17: RETURN PRESSURE AND ALARM #1: AIR DETECTED. THIS CAPA WAS CLOSED AS EFFECTIVE. SERVICE ORDER (B)(4) WAS COMPLETED: FIELD ENGINEER DID CHECKOUT FOR AIR DETECTORS AND COMPLETED SYSTEM CHECKOUT. NO FURTHER ACTION REQUIRED. SINCE MEDICAL INTERVENTION WAS NECESSARY, THIS CASE IS SERIOUS AND REPORTABLE. HOWEVER ANXIETY ATTACK IS PROBABLY RELATED TO THE PATIENT'S UNDERLYING CONDITION. THE SMART CARD WAS RETURNED FOR EVALUATION ON (B)(4) 2014. THIS EVALUATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ANALYSIS OF THE SMART CARD IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AIR IN THE RETURN LINE. SINGLE NEEDLE MODE. CUSTOMER STATED THEIR "NEW OPERATOR" WAS PERFORMING A TREATMENT AND ENCOUNTERED SOME RETURN PRESSURE ALARMS DURING BUFFY COAT COLLECTION. OPERATOR CHECKED FOR KINKS AND FLUSHED THE LINE TO RESOLVE ALARMS. AIR DETECTED ALARM OCCURRED. OPERATOR NOTICED AIR IN THE RETURN LINE. OPERATOR DISCONNECTED THE RETURN LINE FROM THE PATIENT, REMOVED THE RETURN LINE FROM THE AIR DETECTOR, REPLACED IT WITH ANOTHER FLUID-FILLED LINE, AND CONTINUED TREATMENT TO EXPEL THE AIR. WHEN THAT DID NOT CLEAR THE AIR, CUSTOMER PERFORMED A SALINE BOLUS. CUSTOMER STATED THE BOLUS INITIALLY CLEARED THE AIR FROM THE RETURN LINE, BUT THE RETURN RESERVOIR WAS EMPTY WHICH CAUSED THE LINE TO PULL IN ADDITIONAL AIR. OPERATOR NOTICED RED CELLS BACKED UP INTO THE SALINE DRIP CHAMBER. CUSTOMER STATED THE PATIENT WOKE UP AT THIS TIME, APPEARED VERY ANXIOUS, AND STATED, "SOMETHING IS WRONG". UPON WAKING, O2 STATS WERE 88-90%. PATIENT WAS RECENTLY DIAGNOSED WITH MILD PNEUMONIA, AND WAS USING O2 AT HOME. OXYGEN WAS ADMINISTERED TO THE PATIENT WHICH RAISED HIS SATURATION TO 98-100%. EMERGENCY RESPONSE WAS CALLED. PATIENT HAD URGE FOR BM, BUT DID NOT USE THE BATHROOM. CUSTOMER STATED THE PATIENT ANXIETY LASTED APPROXIMATELY 5 MINUTES, AND HAD RESOLVED BY THE TIME EMERGENCY RESPONSE ARRIVED. VITAL SIGNS WERE STABLE, AND PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION OF POSSIBLE AIR EMBOLISM. THE TREATMENT WAS ABORTED. CUSTOMER ASKED IF IT WAS OK TO USE THIS INSTRUMENT AGAIN. CLINICAL SERVICES SPECIALIST ADVISED THE CUSTOMER TO USE THE INSTRUMENT, BUT EMPHASIZED THE IMPORTANCE OF HAVING PROPER WEIGHT VALUES ON THE SCALES PRE AND POST PRIME. CSS DIRECTED THE CUSTOMER TO THE TECHNICAL BULLETIN WHICH LISTS ACCEPTABLE WEIGHTS AND ADVISED THE CUSTOMER TO CALL FOR SUPPORT AND POSSIBLE INSTRUMENT REPAIR IF SHE NOTICES THESE VALUES ARE OUT OF RANGE. CUSTOMER UNDERSTOOD. THE CUSTOMER STATED SHE WILL RETURN THE SMART CARD FOR INVESTIGATION. SHE DID NOT WANT TO RETURN THE KIT DUE TO CONTAMINATION. SERVICE ORDER (B)(4) WAS DISPATCHED. CSS CALLED THE OPERATOR ON (B)(4) 2014 TO OBTAIN AN UPDATE ON THE PATIENT. OPERATOR STATED SHE BELIEVES NO EVIDENCE OF AIR EMBOLISM WAS SEEN. CUSTOMER STATED THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. OPERATOR DID NOT HAVE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783045 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C326

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R