BEUDAMED
    FDA Adverse Event Other Summary report: N

    RBC (RBX) SET, SPECTRA

    MDR report key: 1940952 · Received December 17, 2010

    Report

    Report Number
    1722028-2010-00077
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    April 27, 2009
    Report Date
    November 5, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - VOLUME ISSUE. CLINICAL SPECIALIST ENTERED ALL THE DATA INTO A PREDICTION TOOL AND COULD NOT FIND ANYTHING UNUSUAL. THEIR STARTING NUMBERS SEEMED TO BE VERY CLOSE, BUT THE FINAL VALUES WERE OFF (INLET VOL. 1345 ML, REPLACE 1150 ML, REMOVE 1240 ML). THE REMOVE AND REPLACE VOLUMES WERE ABOUT RIGHT BUT THE INLET WAS ONLY ABOUT 60% OF 2311 ML. INSTEAD OF A 124 MIN PROCEDURE THE RUN ENDED AFTER 72 MIN. ASKED THE OPERATOR ABOUT FLOW RATES AND FOUND OUT THAT WHEN THEY RECORDED THE FIRST VALUES ABOUT 15 MINUTES INTO THE PROCEDURE, THE INLET PUMP RATE WAS 18.6, THE REPLACE PUMP RATE WAS 17.2 AND THE REMOVE PUMP RATE WAS 18.6. THESE NUMBERS DID NOT CORRELATE WITH MY CALCULATED NUMBERS AND DID NOT MAKE ANY SENSE. OPERATOR HAD DONE A BLOOD PRIME USING AN UNDILUTED RBC UNIT (58%). THE OPERATOR STATED THAT THEY START WITH AN ENTERED PT HCT BUT CHANGE TO THE RBC UNIT HCT DURING THE BLOOD PRIME AND THEN REVERT BACK TO THE PT HCT. ADVISED OPERATOR THAT WE DO NOT RECOMMEND CHANGING THE HCT DURING RBCX PROCEDURES. WE RECOMMEND TO EITHER DILUTE THE UNIT TO THE PT'S HCT AND THEREFORE ENTER THE PT'S HCT FOR THE BLOOD PRIME OR USE ALBUMIN TO PRIME AGAIN AND ENTER THE PT'S HCT. SHE RECEIVED AN INVALID REPLACEMENT VOLUME ALARM DURING THE BLOOD PRIME, BUT SHE HAD JUST CLEARED IT AND CONTINUED. SALINE RUN WAS PERFORMED WITH SAME INPUTS AND THE PROBLEM WAS DUPLICATED WHEN THE HCT WAS CHANGED. THE SAME ALARM ALSO OCCURRED. THIS CONFIRMED THAT THE HCT WAS CHANGED DURING THE BLOOD PRIME CAUSING THESE ARTIFICIALLY ELEVATED PUMP FLOW RATES. OPERATOR AGREED THAT THIS WAS OPERATOR ERROR. CONCLUSION: OPERATOR ERROR.

    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. DURING RUN, CUSTOMER REPORTED THAT THEY PERFORMED AN RBCX PROCEDURE ON A (B)(6) CHILD WITH SICKLE CELL. INSTEAD OF THE ENTERED TARGET ENDING HCT OF 30%, THE ACTUAL ENDING HCT WAS 44% (A SECOND SAMPLE SHOWED AN HCT OF 43%). THE OPERATOR HAD OBSERVED THAT APPROXIMATELY HALF-WAY THROUGH THE PROCEDURE TIME (124 MIN), THEY HAD ALMOST REPLACED THE ENTIRE ESTIMATED VOLUME (CALCULATED REPLACE VOLUME 1079, AT 60 MINUTES 950 ML HAD BEEN GIVEN). THE OPERATOR WANTED TO FIND OUT WHY THIS HAPPENED. THE COMPLAINANT WAS UNWILLING TO PROVIDE A PT IDENTIFIER. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR FLUID IMBALANCE DUE TO OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RBC (RBX) SET, SPECTRA SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 950000000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention