BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1022504 · Received April 3, 2008

    Report

    Report Number
    9617787-2008-00008
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 18, 2007
    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 RETURNED DEVICE WAS RECEIVED IN THE FIRM'S ENGINEERING DEPARTMENT. THE REPORTED INABILITY TO PASS CRYOPRESERVATIVE FLUID THROUGH THE TUBING LINE TO THE TRANSFER BAG WAS EVALUATED. THE EXISTENCE OF BLOCKAGE TO FLOW IN THE SMALL BORE TUBING THAT CONNECTS THE SYRINGE FITTING TO THE TRANSFER BAG WAS CONFIRMED. THE BLOCKAGE WAS LOCALIZED NOT AT EITHER END OF THE TUBING BUT IN BETWEEN THE TWO ENDS. A SEQUENCE OF GAS AND LIQUID INJECTIONS WERE MADE FROM THE SYRINGE CONNECTION INTO THE TUBING VIA THE SYRINGE CONNECTOR. THE FIRST SUCH INJECTION WAS ABLE TO OVERCOME A BLOCKAGE IN THE TUBING, BUT IN TURN EXPOSED ANOTHER BLOCKAGE THAT IN TURN REQUIRED PRESSURE TO OVERCOME. AFTER A THIRD APPLICATION OF PRESSURE, A FINAL BLOCKAGE IN THE TUBING WAS FOUND, THAT WOULD NOT YIELD TO THIS SYRINGE PRESSURE. BY MICROSCOPY, THE OBSTRUCTION WAS OBSERVED TO BE "PLUGS" OF THE SAME MATERIAL FROM WHICH THE WALL OF THE TUBING IS COMPOSED. THE POSSIBILITY THAT THESE OBSTRUCTIONS WERE FORMED DURING THE EXTRUDING OF THE TUBING WAS EXCLUDED BECAUSE THE EXTRUSION PROCESS FORMS THE CENTER HOLE AS THE TUBING IS EXTRUDED; THERE WOULD BE NO "EXTRA" PLASTIC AVAILABLE TO FORM INTERMITTENT PLUGS. IT THEN APPEARS THAT THE BLOCKAGES MAY HAVE FORMED DURING THE MANUFACTURING PROCESS. THE TUBING IN QUESTION IS A VERY FINE-BORE TUBE, AND AS SUCH, IS QUITE CAPABLE OF DEVELOPING STRONG CAPILLARY FORCE FOR ANY LIQUID THAT ENTERS. DURING MANUFACTURING, THE PROCESS FOR ATTACHMENT OF THE SYRINGE LUER FITTING TO THE TUBING UTILIZES A SMALL AMOUNT OF SOLVENT APPLIED AT THE PERIPHERY OF THE TUBING. TO PREVENT THE SOLVENT FROM ENTERING THE LUMEN OF THE TUBING, ANY EXCESS SOLVENT IS BLOTTED AWAY. IT IS NEVERTHELESS STILL POSSIBLE THAT A SMALL AMOUNT COULD ENTER THE BORE OF THE TUBING. TO ADDRESS THE POSSIBILITY OF LIQUID ENTERING THE LUMEN, A SMALL PUFF OF AIR IS DRIVEN THROUGH THE TUBING DURING THE ASSEMBLY PROCESS TO ENSURE ANY REMAINING LIQUID IS DRIVEN OUT. IT IS CONCEIVABLE THAT THE PUFF OF AIR MAY HAVE BEEN INADEQUATE, AND INSTEAD OF FULLY CLEARING THE TUBING, THE AIR MAY HAVE DISPERSED THE REMAINING SOLVENT INTO SMALL DROPLETS, LEAVING SOME OF THEM BEHIND TO BRIDGE THE DIAMETER BETWEEN THE INSIDES OF THE WALL OF THE TUBING. THIS WOULD LEAVE THE SOLVENT IN A POSITION TO PARTIALLY DISSOLVE THE INSIDE OF THE TUBING WALLS PRIOR TO EVAPORATING. AFTER EVAPORATION, THE INSIDE OF THE TUBING WALLS WIND UP BEING SEALED WITH A SEPTUM OF THE PLASTIC DERIVED FROM THE PARTIALLY DISSOLVED TUGGING WALL. SUCH A PROCESS COULD LEAVE BEHIND THE WALL MATERIAL IN A PARTITION OR PLUG IN THE BORE. THE FACT THAT THE LUMEN OF THE TUBING IS QUITE SMALL WOULD FACILITATE THE FORMATION OF SUCH SEPTA. EXPERIMENTAL STUDIES HAVE BEEN INITIATED IN THE MANUFACTURING ENGINEERING DEPARTMENT TO VERIFY WHETHER THIS MODEL FOR BLOCKAGE CAN BE INDEPENDENTLY REPRODUCED. IF THIS MODEL CAN BE ESTABLISHED AS A CAUSE FOR THE BLOCKAGES, AN ATTEMPT TO DETERMINE ROOT CAUSE, AND SUBSEQUENT CAPA WILL FOLLOW. SUMMARY: THE USER'S REPORT OF BLOCKAGE WAS CONFIRMED. BASED ON EXAMINATION OF THE RETURNED DEVICE, A MODEL FOR THE CAUSATION OF THE BLOCKAGE HAS BEEN PROPOSED; FURTHER STUDY WILL LEAD TO A POSSIBLE ROOT CAUSE DETERMINATION AND CAPA AS WARRANTED. 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 AND PROCESSED SUCCESSFULLY UNTIL THE STAGE WHEN THE ADDITION OF CYROPRESERVATIVE WAS TO TAKE PLACE. IT WAS NOTED BY THE TECHNICIAN THAT THE FREEZING MEDIA WOULD NOT PUSH THROUGH THE LINE THAT GOES TO THE SMALL COMPARTMENT OF THE FREEZER BAG COMPONENT OF THE DEVICE. THE TECHNICIAN TRANSFERRED THE CORD BLOOD PRODUCT INTO ANOTHER TRANSFER SET WITH ABOUT 0.5ML LOST DURING THE TRANSFER. THE UNIT WAS THEN PROCESSED WITHOUT FURTHER 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 0753046

    Patients

    Seq Age Sex Outcome Treatment
    1