BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD

    MDR report key: 1563648 · Received December 23, 2009

    Report

    Report Number
    9617787-2009-00039
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 24, 2009
    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

    L/N 0853153 - MANUFACTURED 11/05/2008, EXPIRES 11/05/2011.L/N 0853130 - MANUFACTURED 10/16/2008, EXPIRES 10/16/2011.L/N 0853139 - MANUFACTURED 10/25/2008, EXPIRES 10/24/2011.

    Additional Manufacturer Narrative · 1

    UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT PROBLEMS WITH SENSOR AND BLOOD GLUCOSE READINGS, AS WELL AS CALIBRATION ERRORS. THE CUSTOMER THEN STATED THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS IN THE RANGE OF 30 MG/DL. THE CUSTOMER STATED THAT HE WENT LOW BECAUSE HAD GIVEN HIMSELF A BOLUS FOR FOOD THAT HE WAS ABOUT TO EAT, BUT HE CHANGED HIS MIND, ATE SOMETHING ELSE, THEN WENT TO SLEEP. THE CUSTOMER KNEW THAT IT WAS HIS ERROR, AND DECLINED FURTHER TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A (B) (6) THAT THE MEMBRANE ABOVE THE SMALL COMPARTMENT OF THE FREEZING BAG DID NOT SEAL WELL, RESULTING IN (B) (6) PRODUCT FLOWING INTO THE OUTER MEMBRANE NOTED AT THE STEP OF TRANSFERRING THE BLOOD INTO THE FREEZING BAG. DATE OF OCCURRENCES WAS REPORTED FROM (B) (6) 2009 THROUGH (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD TRANSFER/FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02T 0853153, 0853139, 0853130

    Patients

    Seq Age Sex Outcome Treatment
    1