BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1945877 · Received December 8, 2010

    Report

    Report Number
    1219702-2010-00006
    Event Type
    Other
    Date Received
    December 8, 2010
    Product Code
    FPA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SET #1 WAS RECEIVED ON (B)(6), 2010. FLUID LEAKAGE WAS CONFIRMED AND THE POINT OF FAILURE WAS VISUALLY IDENTIFIED TO BE ALONG THE JOINT FORMED BETWEEN THE NOZZLE-HEAT EXCHANGER PLENUM. THE PRESENCE OF A SMALL IMPACT DEPRESSION AND INDICATIONS OF COHESIVE FAILURE WITHIN THE JOINT SUPPORTS THE POSSIBILITY OF THE DISPOSABLE SET BEING DAMAGED OUTSIDE OF THE CONFINES OF THE TRAY/POUCH EITHER BY SUSTAINING A MECHANICAL BLOW OR ATTEMPTING INSTALLATION OF THE SET INTO THE PUMP UNIT INCORRECTLY. THERE IS NO EVIDENCE TO SUGGEST THAT THE JOINT FAILURE OCCURRED PRIOR TO OR WHILE IN SERVICE DUE TO ADHESIVE FAILURE AS A RESULT OF EXPOSURE TO MOISTURE AND/OR OTHER ENVIRONMENTAL FACTORS. THE MAGNITUDE OF THE LEAK PATH WAS CONFIRMED TO BE WELL WITHIN OUR DETECTABLE LIMITS AS STABLE TEST PRESSURES COULD NOT BE OBTAINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE NOZZLE-PLENUM JOINT FAILURE THAT RESULTED IN FLUID LEAKAGE OCCURRED AS A RESULT OF WORKMANSHIP, DESIGN, MATERIALS, PRODUCTION PRACTICES, OR NEGLIGENCE BY BELMONT INSTRUMENT. SET #2, RECEIVED ON (B)(4), 2010: FLUID LEAKAGE WAS CONFIRMED AND THE POINT OF FAILURE WAS VISUALLY IDENTIFIED TO BE ALONG THE OUTER CIRCUMFERENTIAL WELD BETWEEN THE HEAT EXCHANGER ASSEMBLY TOP AND BOTTOM COMPONENTS. THE CRACK, ORIGINATING FROM A POINT OF HIGHLY CONCENTRATED MECHANICAL STRESS, ATYPICAL OF A MFG ARTIFACT, WITH ADDITIONAL CRACKS PROPAGATING PERPENDICULAR THROUGH THE WELD AS WELL. THIS HIGHLY CONCENTRATED MECHANICAL STRESS INDICATING THE POSSIBILITY OF THE HEAT EXCHANGER ASSEMBLY BEING DAMAGED OUTSIDE THE CONFINES OF THE TRAY/POUCH EITHER BY SUSTAINING AN IMPACT OR DROP, OR EXPOSURE TO A CONCENTRATED COMPRESSIVE FORCE. THE 3-SPIKE SETS, P/N 903-00006, MFG ARE ROUTINELY TESTED 100% BY AIR PRESSURE DECAY, PRIOR TO POUCHING AND STERILIZATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE JOINT FAILURE OCCURRED PRIOR TO, OR WHILE IN SERVICE, DUE TO ADHESIVE FAILURE, AS A RESULT OF EXPOSURE TO MOISTURE AND/OR OTHER ENVIRONMENTAL FACTORS. THE MAGNITUDE OF THE LEAK PATH WAS CONFIRMED TO BE WELL WITHIN DETECTABLE LIMITS AS STABLE TEST PRESSURES COULD NOT BE OBTAINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE HEAT EXCHANGER ASSEMBLY FLUID LEAK OCCURRED AS A RESULT OF WORKMANSHIP, DESIGN, MATERIALS, PRODUCTION PRACTICES, OR NEGLIGENCE BY BELMONT INSTRUMENT. WE SHIPPED MORE THAN 40,000 SETS EACH YR AND HAVE NOT HAD A SIMILAR REPORT OF THIS TYPE OF INCIDENT FROM ANY OTHER HOSP.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FPA

    Patients

    Seq Age Sex Outcome Treatment
    1