BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL BACTERIA DETECTION SYSTEM FOR LUKOCYTE-REDUCED PLATELET TRANSFUSION PRODUCT

    MDR report key: 1251183 · Received December 5, 2008

    Report

    Report Number
    9617787-2008-00023
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    PALL LIFE SCIENCES PUERTO RICO, LLC
    Product Code
    MZC
    PMA / PMN Number
    BK030082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE OF AN APHERESIS PLATELET UNIT WAS COLLECTED IN 2008 AT A BLOOD CENTER INTO THE DEVICE'S SAMPLING POUCH, AND WAS TESTED USING THE DEVICE FOR % HEAD-SPACE OXYGEN AND MEASURED AT 16.78% (PASS) TWO DAYS LATER. THAT APHERESIS UNIT WAS SPLIT INTO TWO PLATELET PRODUCTS AND BOTH WERE SENT TO A TRANSFUSION SERVICE. IT IS THE POLICY OF THAT SERVICE TO CULTURE SAMPLES OF PLATELET UNITS TAKEN JUST PRIOR TO TRANSFUSION. ONE SPLIT PRODUCT SAMPLE TESTED CULTURE-NEGATIVE THE SAME DAY. THE SECOND SPLIT UNIT SIMPLE TESTED POSITIVE: GROWTH FROM A "DIRECT SMEAR WAS REPORTED AS 2+ GPC IN CLUSTERS AND THEN IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS AT 1 X 10E6 CFU/ML S". BOTH SPLIT PLATELET PRODUCTS WERE ADMINISTERED TO PATIENTS, AND NO TRANSFUSION REACTIONS WERE NOTED. INVESTIGATION: A SLANT FROM THE BACTERIAL ISOLATE WAS SENT TO THE FIRM'S LABORATORIES FOR EVALUATION. THE FIRM'S INVESTIGATION CONSISTED OF THE FOLLOWING: REVIEW OF THE DATALOG OF ALL TESTING FROM THE DEVICE FROM THE DATE THE UNIT IN QUESTION WAS TESTED. REVIEW OF THE MANUFACTURING RECORD OF THE SAMPLING POUCH. GROW-OUT AND EVALUATION OF THE ISOLATES FROM THE CULTURES GROWN AT THE TRANSFUSION SERVICE. RESULTS: REVIEW OF THE DATA LOGS FROM THE DEVICE REVEALED THAT FOR THE DAY THE INVOLVED PLATELET UNIT WAS TESTED, 10/15/2008, ALL THE BASELINE AND TEST VALUES WERE TYPICAL OF THOSE EXPECTED FOR A TRUE NEGATIVE DETERMINATION. REVIEW OF THE MANUFACTURING RECORDS OF THE DEVICE'S SAMPLING POUCHES FOR THE INVOLVED POUCH LOT NUMBER DISCLOSED NO DEVIATION FROM SOPS OR RELEASE TESTING REQUIREMENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO AN INCORRECT DETERMINATION. GROW-OUT AND EVALUATION OF THE ISOLATES FROM THE TRANSFUSION SERVICE'S CULTURES. STUDY DESIGN: LOW LEVELS OF THE BACTERIA GROWN OUT FROM THE ISOLATES (1-15 CFU/ML) WERE INOCULATED INTO PLATELET CONCENTRATES, AND AFTER THE INCUBATION PERIODS, WERE TESTED FOR CONTAMINATION WITH THE DEVICE. THE CRITERION FOR A DETERMINATION OF CONTAMINATION IS LESS THAN 9.4% OXYGEN. THE SAMPLE UNITS ALL FAILED WITH AN AVERAGE OXYGEN READING OF 0.69%. THEREFORE, THE MICROORGANISM IN THE BACTERIA ISOLATE HAS THE POTENTIAL TO BE DETECTED BY THE DEVICE. CONCLUSIONS: BASED ON THE INFORMATION AT HAND, IT IS POSSIBLE THE DEVICE'S DETERMINATION OF PASS (NO CONTAMINATION) WAS THE RESULTS OF A LOW CFU COUNT (< 1 CFU/ML) ) IN THE APHERESIS UNIT, RESULTING IN NO VIABLE BACTERIA BEING CONTAINED IN THE DEVICE'S SAMPLE POUCH. ALTERNATIVELY, THE SLOW GROWTH CHARACTERISTIC OF S. EPIDERMIDIS MAY HAVE NOT REDUCED THE OXYGEN IN THE HEADSPACE DURING THE INCUBATION PERIOD SUFFICIENTLY TO RESULT IN A FAIL READING. THE FIRM'S EXPERIENCE WITH THE VARIABILITY OF THE DEVICE IN DETECTING THE SLOW-GROWING S. EPIDERMIDIS IS REFLECTED IN THE DATA PUBLISHED IN THE DEVICE LABELING. IT IS POSSIBLE THAT FOR THE 2-DAY OLD SPLIT PLATELET PRODUCT THAT CULTURED NEGATIVE, THE BACTERIAL CONTAMINATION WAS MISSED DUE TO THE SAMPLE VOLUME NOT CONTAINING A VIABLE BACTERIUM DUE TO THE STATISTICAL DISTRIBUTION OF BACTERIA IN A LOW CFU LEVEL OF CONTAMINATION. . ALTERNATIVELY, THESE RESULTS COULD REFLECT ARTIFACTUAL CONTAMINATION OF THE OTHER SPLIT PLATELET PRODUCT DURING THE HOSPITAL LABORATORY SAMPLING AT 5 DAYS OR ITS TESTING. IN SUMMARY, THE ORIGIN OF THE APPARENT FALSE NEGATIVE IS UNCERTAIN, BUT IT DOES NOT APPEAR THAT THE DEVICE MALFUNCTIONED. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS LATE DUE TO THE FACT THAT THE PRODUCT CODE OF MZC WAS NOT IN THE PRODUCT CODE LISTING. I LEFT SEVERAL MESSAGES ON NOVEMBER 21 FOR NUMEROUS FDA/CDRH EMPLOYEES, BUT DID NOT RECEIVE A RETURN PHONE CALL FROM ANYONE. AN E-MAIL WAS ALSO SENT TO (B) (4) ON NOVEMBER 20 EXPLAINING MY PROBLEM. THERE WAS ALSO A PROBLEM WITH THE ELECTRONIC SIGNATURE. I E-MAILED (B) (4) ON 12/2 REGARDING THIS PROBLEM. I ALSO CALLED ON 12/3 AND LEFT A VOICE MAIL. I ALSO SENT THIS PROBLEM TO (B) (4) ON 12/3. ON 12/4 RECEIVED AN E-MAIL FROM (B) (4) TO SEND THE E-MAIL TO (B) (4), WHICH I DID. (B) (4) REPLIED THAT THE PROBLEM APPEARS TO BE ON (B) (4) END. CALLED (B) (4) AT (B) (4) ON 12/5 AND LEFT A VOICE MAIL FOR HIM TO CALL ME BACK TO WORK WITH ME AND (B) (4), IT DEPARTMENT TO RESOLVE THIS PROBLEM.

    Description of Event or Problem · 1

    A BLOOD CENTER REPORTED THAT A SAMPLE OF AN APHERESIS PLATELET UNIT THAT WAS COLLECTED WAS TESTED FOR BACTERIAL CONTAMINATION USING THE DEVICE AND THE RESULT WAS NEGATIVE. THAT APHERESIS UNIT WAS SPLIT INTO TWO PLATELET PRODUCTS AND BOTH WERE SENT TO A HOSPITAL TRANSFUSION FACILITY. IT IS THE POLICY OF THAT HOSPITAL TO CULTURE SAMPLES OF PLATELET UNITS TAKEN JUST PRIOR TO TRANSFUSION. ONE SPLIT 3-DAY-OLD PRODUCT SAMPLE TESTED CULTURE-NEGATIVE. THE SECOND SPLIT UNIT SAMPLE, AT 5 DAYS OF AGE, TESTED POSITIVE: GROWTH FROM A DIRECT SMEAR WAS REPORTED AS 2+ GRAM-POSITIVE COCCI IN CLUSTERS AND THEN IDENTIFIED AS (B) (6) EPIDERMIDIS AT 1X 10E6 CFU/ML. BOTH SPLIT PLATELET PRODUCTS WERE ADMINISTERED TO PATIENTS AND NO TRANSFUSION REACTIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BACTERIA DETECTION SYSTEM FOR LUKOCYTE-REDUCED PLATELET TRANSFUSION PRODUCT BACTERIAL DETECTION SYSTEM FOR PLATELET TRANSFUSION PRODUCTS MZC PALL LIFE SCIENCES PUERTO RICO, LLC 400-03 0854016

    Patients

    Seq Age Sex Outcome Treatment
    1