BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1973088 · Received January 19, 2011

    Report

    Report Number
    1722028-2011-00005
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CARIDIAN BCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECTRA USES THE PT PARAMETERS THAT ARE ENTERED TO CALCULATE THE PROPER REPLACEMENT VOLUME IN ORDER TO ACHIEVE THE DESIRED TARGET, IF THIS INFO IS NOT ACCURATE, THIS CAN AFFECT THE FINAL OUTCOME TO BE DIFFERENT FROM WHAT WAS TARGETED. A SERVICE CALL WAS PLACED TO CHECK OUT THE EQUIPMENT. THE SERVICE REP CHECKED THE VALVES AND PUMPS FOR ACCURACY; HE ALSO CHECKED THE PUMP ALIGNMENT, ROTOR OCCLUSION, AND PUMP SPEEDS WITH NO PROBLEMS FOUND. INVESTIGATION: IN THIS INCIDENT, SEVERAL ASPECTS OF THE PROCESS COULD HAVE CONTRIBUTED TO A LOWER THAN EXPECTED ENDING HEMATOCRIT OF THE PT: THE TBV CALCULATION MIGHT NOT HAVE BEEN AS ACCURATE DUE TO THE PT BEING UNDER (B)(4), THE MANUAL PRIMING PROCEDURE OF THE SET CAUSING THE HCT OF THE FIRST 50 MLS TO BE LESS THAN THE 61%, AND THE FACT THAT SINCE THE PT RECEIVED FLUIDS ON THE WAY TO THE HOSPITAL, HER STARTING HCT MAY HAVE BEEN INCORRECT. DURING TRAINING, CUSTOMERS ARE TAUGHT THAT THE ALGORITHM IN SPECTRA USED FOR THE CALCULATION OF TBV IS BASED ON ADULTS AND THAT IT MAY NOT BE ACCURATE FOR A PEDIATRIC PT UNDER (B)(4). THEY ARE TOLD TO CONSULT WITH A PHYSICIAN ABOUT THE APPROPRIATE TBV TO USE IN THESE CASES. SPECTRA ALLOWS FOR AN OPERATOR TO ENTER A HEMATOCRIT MANUALLY IF REQUIRED. CONCLUSION: LIKELY, THE ISSUE WAS DUE TO A COMBINATION OF PROCESS ERRORS, BUT THIS CANNOT BE UNEQUIVOCALLY PROVEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DESIRED ENDING HEMATOCRIT WAS LOWER THAN EXPECTED. THE PT RECEIVED A UNIT OF RED CELLS TO HELP RECOVER THEIR HEMATOCRIT. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY DUE TO LOWER THAN DESIRED ENDING HEMATOCRIT AND MEDICAL INTERVENTION IN THE ADMINISTRATION OF ADDITIONAL RED CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND P1 LKN CARIDIAN BCT 950000000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other