BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1022503 · Received April 3, 2008

    Report

    Report Number
    9617787-2008-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ENTASEC 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETUNED BY THE REPORTER AND SUBJECTED TO AN ENGINEERING EVALUATION. THE USER REPORTED THAT, AFTER USING AN EXTERNAL SEALER TO SEAL BOTH THE UPPER AND LOWER CONDUITS LEADING FROM THE LARGE TO SMALL CHAMBER OF THE FREEZING BAG, A SMALL AMOUNT OF CORD BLOOD PRODUCT WAS OBSERVED TO BE LEAKING FROM THE LOWER SEAL, ADJACENT THE LARGER CHAMBER. A REVIEW OF THE MANUFACTURING HISTORY OF THE LOT REPRESENTED BY THE INVOLVED DEVICE DID NOT DISCLOSE ANY DEVIATION FROM STANDARD PROCEDURES OR FAILURE TO PASS RELEASE TESTING REQUIREMENTS. UPON RECEIPT OF THE DEVICE, THE PRESENCE OF THE REPORTED HOLE AND SUBSEQUENT LEAKAGE WAS CONFIRMED. DURING MICROSCOPIC EXAMINATION, A FLATTENED AREA WAS VISIBLE JUST TO THE LEFT OF THE CENTERLINE OF THE HOLE, DESCENDING AT AN ANGLE OFF TO THE LEFT. A SMOOTH PERIMETER CLEARLY SEEN ON THE RIGHT HALF OF THE HOLE, AND DARK MARKINGS WERE PRESENT ON THE LEFT PERIMETER. THE FLATTENED AREA WAS IDENTIFIED TO BE THE FOOTPRINT OF THE HEAT SEALING TOOL, WHICH APPEARED TO HAVE BEEN APPLIED AT AN ANGLE TO THE USUAL POSITIONING OF THE SEALER.THE APPEARANCE OF THE HOLE, INCLUDING THE SMOOTH MELTED EDGE AND THE DARK MARKINGS, STRONGLY SUGGESTS IT RESULTED FROM AN ARC-OVER OF THE ELECTRODES OF THE SEALER. IF THE ARC-OVER HAPPENED IN THE MIDDLE OF THE ALREADY-SEALED PORTION OF THE BAG BETWEEN THE CHAMBERS, IT MIGHT HAVE GONE UNNOTICED. HOWEVER, COMBINED WITH THE ANGLING OF THE SEALER TOWARDS THE LARGER CHAMBER, THE HOLE WAS FORMED JUST INSIDE THE BOUNDARY OF THE LARGER PORTION OF THE BAG, CAUSING THE LEAK. THE FIRM HAS BEEN IN DISCUSSION WITH THE MANUFACTURER OF THE HEAT-SEALER TO REDUCE THE FREQUENCY OF SUCH ARC-OVERS, AND A MODIFIED SEALER HEAD HAS BEEN DEVELOPMENT THAT IS EXPECTED TO REDUCE SIGNIFICANTLY THE INCIDENCE OF SUCH ARC-OVERS. SUMMARY: THE USER'S REPORT OF A HOLE AFTER HEAT-SEALING WAS CONFIRMED. THE HOLE APPEARED TO HAVE BEEN CREATED IN A DEVICE THAT WAS WITHIN SPECIFICATION AS A RESULT OF AN IMPROPER HEAT SEAL. THE MORPHOLOGY OF THE SEAL INDICATES THE ROOT CAUSE WAS A COMBINATION OF USE ERROR (MIS-POSITIONING OF THE SEALER HEAD) AND THE PROPENSITY OF THE MODEL OF HEAT SEALER THAT WAS USED TOWARD ARC-OVERS.UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CORD BLOOD PROCESSING FACILITY THAT A UNIT OF CORD BLOOD WAS TRANSFERRED INTO THE DEVICE, A TRANSFER/FREEZER BAG SET WHICH WAS MANUFACTURED FOR THE AUTOMATED SEPAX SYSTEM. AFTER COMPLETING THE BOTTOM SEAL OF THE LARGE COMPARTMENT OF THE FREEZER BAG, THE TECHNICIAN NOTICED A SMALL AMOUNT OF CORD BLOOD PRODUCT LEAKING FROM THE SEAL. THE TECHNICIAN DISCONNECTED THE SMALL COMPARTMENT OF THE FREEZER BAG AND THE TUBING SEGMENTS, AND TRANSFERRED THE CORD BLOOD PRODUCT IN THE LARGE COMPARTMENT INTO A NEW TRANSFER SET. APPROXIMATELY 1ML OF CORD BLOOD PRODUCT WAS LOST. THE CORD BLOOD UNIT WAS THEN FURTHER PROCESSED WITHOUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1