BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1080971 · Received July 25, 2008

    Report

    Report Number
    9617787-2008-00017
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY FOR THE LOT NUMBER REPORTED REVEALED NO DEVIATION FROM ESTABLISHED PROCESS AND PRODUCT RELEASE TEST REQUIREMENTS HAD BEEN MET. ENGINEERING ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE REPORTER'S OBSERVATION, AND ESTABLISHED THAT THIS DEVIATION IS THE SAME PROXIMATE CAUSE AS THE EVENT THAT WAS REPORTED AS 9617787-2008-00008, AND HERE HAVING OCCURRED IN A SUBSEQUENT MANUFACTURING LOT. IN THE TIME PERIOD SINCE THE 9617787-2008-00008 REPORT, A ROOT CAUSE HAS BEEN IDENTIFIED, NAMELY, THAT THE EXISTING IN-PROCESS ON-LINE TEST FOR TUBING LUMEN PATENCY WAS INADEQUATE TO IDENTIFY THE PRESENCE OF SMALL AMOUNTS OF RESIDUAL SOLVENT THAT WERE ABLE TO GENERATE BLOCKAGE DURING LATER STEPS IN DEVICE PRODUCTION. AS A CAPA, AN ADDITIONAL TEST FOR FLOW PATHWAY PATENCY WAS ADDED AFTER THE FINAL STEP OF ASSEMBLY. IT IS EXPECTED THAT THIS 100% TEST FOLLOWING PRODUCT COMPLETION WILL IDENTIFY AND REJECT THE TYPE OF DEVIATION RESPONSIBLE FOR THIS EVENT. THIS ADDITIONAL TEST WAS IMPLEMENTED AFTER 2008, AND IS BEING MONITORED FOR EFFECTIVENESS. SUMMARY THE USER'S REPORT WAS CONFIRMED, AND IDENTIFIED TO BE OF THE SAME NATURE OF A PREVIOUS EVENT. THE ROOT CAUSE WAS IDENTIFIED AND A CAPA HAS BEEN INITIATED. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE PROCESSING OF UMBILICAL CORD BLOOD, THE CORD BLOOD PRODUCT IN THE 200ML TRANSFER BAG COMPONENT OF THE DEVICE WAS ABOUT TO HAVE CYROPRESERVATIVE ADDED TO THE BAG. IT WAS NOTED BY THE TECHNICIAN THAT THE FREEZING MEDIA WOULD NOT FLOW THROUGH THE LINE THAT LEADS TO THE 200 ML TRANSFER BAG. THE TECHNICIAN TRANSFERRED THE REMAINING CORD BLOOD PRODUCT INTO ANOTHER TRANSFER/FREEZING BAG SET WITH ABOUT 2 ML LOST DURING THE TRANSFER. THE CORD BLOOD PRODUCT WAS THEN PROCESSED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET PALL TRANSFER/FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02 0853021

    Patients

    Seq Age Sex Outcome Treatment
    1