BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1942453 · Received December 21, 2010

    Report

    Report Number
    1722028-2010-00117
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    March 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE CALL WAS PLACED TO CHECK OUT THE EQUIPMENT AND, SPECIFICALLY, THE CCM. THE SERVICE REP FOUND THE AC PUMP HOUSING OUT OF ALIGNMENT, THE CENTRIFUGE PRESSURE SENSOR NEEDED TO BE RESEATED, AND THAT THE RBC DETECTOR AND CCM WERE OUT OF CALIBRATION. HE BROUGHT ALL PARTS BACK WITHIN MFG SPECIFICATIONS. IN THE SPECTRA ESSENTIALS GUIDE OPERATOR'S MANUAL, THE OPERATOR IS WARNED ON PG 1-10 THAT "WHEN USING BIOLOGICALLY DERIVED REPLACEMENT FLUIDS, [THEY SHOULD] CLOSELY MONITOR THE PT FOR REACTIONS". FURTHER THEY ARE CAUTIONED THAT ALTHOUGH "THE SPECTRA SYSTEM HAS MANY SAFETY FEATURES, A DONOR AND/OR PT REACTION CAN OCCUR RAPIDLY. IT IS IMPERATIVE THAT THE OPERATOR CONTINUOUSLY MONITOR THE SPECTRA SYSTEM AND THE DONOR AND/OR PT." THERE WAS A SMALL CITRATE REACTION IN WHICH THE STAFF RESPONDED CORRECTLY TO THE ISSUE BY ADMINISTERING CALCIUM. RELATED TO THE YIELD ISSUES, THERE COULD HAVE BEEN SEVERAL CAUSES, INCLUDING PT MOBILIZATION, HARVEST FREQUENCY, VOLUME PROCESSED, ACCESS PRESSURE LOW ALARMS, INTERFACE POSITION, LAB MEASUREMENTS AND CALCULATIONS, HOWEVER, THE RISK MGR WAS UNABLE TO GIVE MANY DETAILS REGARDING THESE POSSIBILITIES FOR THIS PROCEDURE. TRENDING INDICATES THAT THIS IS AN INFREQUENT ISSUE. UNDETERMINED; IT IS POSSIBLE THAT THERE IS A PROCEDURE OR PT RELATED CAUSE FOR THE YIELD ISSUES BUT THIS CANNOT BE UNEQUIVOCALLY PROVEN. CONCLUSION: CITRATE REACTIONS ARE A KNOWN SIDE EFFECT OF THIS PROCEDURE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE CUSTOMER REPORTED THAT THEY DID NOT ACHIEVE THE DESIRED YIELD AND THAT THE PT WAS HYPER ANTI-COAGULATED DURING A WBC-AUTOPBSC PROCEDURE. UPON F/U, THE CUSTOMER STATED THAT THERE WAS NO HEMATOMA EVENT DURING THE PROCEDURE, BUT THAT THE PT DID EXPERIENCE A SLIGHT CITRATE REACTION, TINGLING SENSATION ON HIS LIPS, WHICH WAS RESOLVED WITH 1 GRAM CALCIUM GLUCONATE IV. COMPLAINANT WAS UNWILLING TO PROVIDE PT ID INFO. THIS REPORT IS BEING SUBMITTED DUE TO MEDICAL INTERVENTION IN RESPONSE TO THE CITRATE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 950000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention