BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE

    MDR report key: 1060686 · Received June 18, 2008

    Report

    Report Number
    2647898-2008-00002
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 27, 2008
    Manufacturer
    PALL LIFE SCIENCES PUERTO RICO, LLC
    Product Code
    JOD
    PMA / PMN Number
    K875095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AT ITS MANUFACTURING FACILITY. A REVIEW OF THE DEVICE HISTORY FILE WAS NOT POSSIBLE BECAUSE THE USER DID NOT REPORT THE LOT NUMBER. VISUAL INSPECTION CONFIRMED THE REPORTED DEVIATION. THE DEVICE RETURNED INCLUDED ONE YELLOW MOVABLE PARTICLE INSIDE THE FILTER OUTLET HOUSING. USING A SIZE EXAMINATION CHART, THE SURFACE AREA WAS APPROXIMATELY 3.00 SQUARE MILLIMETERS. THIS PARTICLE APPEARED TO BE A FRAGMENT OF THE DEVICE'S END CAP MATERIAL. THIS TYPE OF PARTICLE MAY BE GENERATED DURING THE MANUFACTURING PROCESS OF END CAPPING. A VISUAL INSPECTION PROCEDURE OCCURS FOLLOWING END CAPPING, AND INCLUDES PARTICULATES AS PART OF THE INSPECTIONAL TARGETS. IT IS POSSIBLE THAT THE INSPECTOR COULD NOT SEE THE PARTICLE BECAUSE OF ITS POSITION IN THE DEVICE, OR THAT THE INSPECTOR FAILED TO PERCEIVE A VISIBLE PARTICLE. SUMMARY: THE USER'S REPORT WAS CONFIRMED. THE PROXIMATE CAUSE APPEARED TO BE MANUFACTURING OPERATOR ERROR IN NOT DETECTING THE DEVIATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED. IT IS NOTED THAT A GENERAL PARTICULATE REDUCTION PLAN WAS IMPLEMENTED IN REVISION IN MARCH OF 2008. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ASSEMBLY OF THE DEVICE INTO TUBING AT A TUBING PACK MANUFACTURER, A YELLOW PARTICLE WAS SEEN IN THE DOWNSTREAM HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE 0.2 MICRON CARDIOPLEGIA FILTER JOD PALL LIFE SCIENCES PUERTO RICO, LLC CPS02NS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1