BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING B AG SET FOR PROCESSING AND FREEZING CORD BLOOD

    MDR report key: 1060684 · Received June 18, 2008

    Report

    Report Number
    9617787-2008-00016
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE REPORTER REPORTED THAT A LEAK APPEARED NEAR THE SPIKE. FROM THIS REPORT, IT IS NOT CLEAR WHETHER OR NOT THE CUSTOMER WAS ABLE TO FINISH THE PROCESSING OF THIS UNIT. THE INVOLVED DEVICE WAS NOT RETAINED FOR FURTHER EVALUATION. HOWEVER, THE REPORTER WAS ABLE TO PROVIDE A PICTURE OF THE AREA OF THE LEAK, WITH WHAT APPEARS TO BE A BUBBLE OF BLOOD AT THE LEAK SITE.WHILE THE PICTURE DOES HIGHLIGHT THE LEAK AREA, BUT WITHOUT THE ABILITY TO EXAMINE THE SITE MICROSCOPICALLY, IT IS ONLY POSSIBLE TO SURMISE. DURING ASSEMBLY, THE SMALLER BORE 3MM PVC TUBE IS INSERTED AND BONDED INTO THE LARGER BORE PVC TUBING, WHICH IS FINALLY BONDED TO THE SPIKE. THE CLEAR DEMARCATION BETWEEN THE BLOOD IN THE 3MM TUBING AND WHERE IT IS BONDED TO THE LARGER TUBING SUGGESTS THE JOINT WAS PROPERLY MADE. THE LEAK ITSELF APPEARS ALIGNED JUST TO THE LEFT OF THE LOCATION WHERE THE 3MM INNER PVC TUBE ENDS IN THE LARGER TUBE, BUT THE PRESENCE OF THE DISK OF BLOOD INSIDE THE LARGER BORE TUBING, JUST TO THE RIGHT OF THE LEAK ITSELF, IS PUZZLING. IT IS WORTHY TO NOTE THAT THE REMAINDER OF THE TUBE TO THE LEFT IS FREE OF BLOOD (WHERE YOU WOULD EXPECT TO SEE IT), AND, IN ANY CASE, BLOOD USUALLY DOESN'T FORM SUCH NEAT DISKS IN TUBING. IT MAY BE SIGNIFICANT, OR JUST AN ARTIFACT CREATED WHILE DEMONSTRATING THE LEAK.AS TO THE SOURCES OF THE LEAK, THERE ARE NO SHARP OBJECTS USED DURING THE MANUFACTURING STEPS (LIKE A NEEDLE) THAT COULD HAVE PUNCTURED THE TUBING, SO THE CAUSE OF THE LEAK CANNOT BE ASCERTAINED.A REVIEW OF THE MANUFACTURING HISTORY FOR THE PRODUCT LOT INVOLVED DID NOT REVEAL ANY DEVIATION IN PROCESS OR IN THE RESULTS OF RELEASE TESTING.SUMMARY:THE CUSTOMER'S OBSERVATION IS CONFIRMED IN A GENERAL SENSE. HOWEVER, IN THE ABSENCE OF THE DEVICE ITSELF, THE PROXIMATE AND ROOT CAUSES REMAIN INDETERMINATE. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCESSING OF CORD BLOOD, A LEAK WAS OBSERVED ON THE TUBING AREA JUST OUTSIDE THE TRANSFER SPIKE ON THE 200 ML BAG NOTED BEFORE ADDING IN THE DMSO?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING B AG SET FOR PROCESSING AND FREEZING CORD BLOOD TRANSFER FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02T 0753151

    Patients

    Seq Age Sex Outcome Treatment
    1