BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL CELL WASH/INFUSION BAG SET

    MDR report key: 1252323 · Received December 8, 2008

    Report

    Report Number
    9617787-2008-00024
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 17, 2008
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE REPORTER INDICATED THAT THE USED DEVICE WOULD BE RETURNED FOR INVESTIGATION, IT WAS NOT FORTHCOMING. THEREFORE A DIRECT ANALYSIS WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING HISTORY FOR DEVICE LOT NUMBER 0653069 REVEALED THAT THIS LOT WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED DEVIATION. A REVIEW OF COMPLAINT FILES DISCLOSED THAT NO OTHER REPORTS FOR THIS DESCRIPTION AND LOT NUMBER HAVE BEEN RECEIVED AND WE THEREFORE BELIEVE THAT THIS IS AN ISOLATED OCCURRENCE. SUMMARY: THE BASIS OF THE REPORTED MALFUNCTION REMAINS INDETERMINATE. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    A STEM CELL TRANSPLANT LABORATORY REPORTS THAT WHILE PROCESSING A THAWED CORD BLOOD UNIT USING THE DEVICE, ONE ITS THE SPIKES AT THE END OF THE CONNECTOR LINE TUBING COMPLETELY DETACHED AND FELL OFF FROM THE SET. THE DETACHMENT OCCURRED DURING THE TECHNICIANS SPIKING INTO THE CORD BLOOD UNIT. THE REPORTER SURMISED THAT THE SPIKE WAS NOT PROPERLY ADHERED TO THE TUBING DURING MANUFACTURING. A NEW DEVICE WAS ATTACHED TO THE CORD BLOOD UNIT AND PROCESSING WAS COMPLETED WITHOUT FURTHER INCIDENT. OVERALL THERE WAS A 1ML LOSS OF STEM CELLS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL CELL WASH/INFUSION BAG SET CELL WASH/INFUSION BAG SET KSR ENSATEC, S.A. DE C.V. 791-03 0653069

    Patients

    Seq Age Sex Outcome Treatment
    1