BEUDAMED
    FDA Adverse Event Summary report: N

    CUSTOM DEFINED DEVICE

    MDR report key: 2902120 · Received January 8, 2013

    Report

    Report Number
    2015691-2013-19037
    Date Received
    January 8, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE COMPLAINT UNIT IDENTIFIED A DIFFERENT FAILURE THAT THE ONE REPORTED. WE RECEIVED (B)(4) CUSTOM KIT WITH A BIFURCATED IV LINE AND ATTACHED MERIT FLUSH DEVICES. THE VENTED CAPS WERE STILL ATTACHED AT THE DISTAL ENDS OF THE PRESSURE LINE. THERE WAS NO VISIBLE BLOOD FOUND AT THE DISTAL TUBING MALE CONNECTORS. IN ADDITION, THERE WAS NO LEAKAGE FOUND IN THE KIT DURING LEAK TESTING. ALL CONNECTIONS APPEARED TIGHT. THE FLOW RATE OF ONE OF THE MERIT FLUSH DEVICES MET THE SPECIFICATION OF 2- 4ML/HR, PER THE IFU. HOWEVER, THE FLOW RATE OF THE OTHER MERIT FLUSH DEVICE DID NOT MEET IFU SPECIFICATION; FLOW MEASURED AN AVERAGE OF 25.6ML/HR. IT APPEARED THAT THE FLUSH DEVICE HOUSING WAS NOT ASSEMBLED STRAIGHT AND THIS AFFECTED THE FLOW RATE. THE COMPLAINT WAS RELATED TO A MANUFACTURING NON-CONFORMANCE OF THE MERIT SUPPLIED DEVICE. ROOT CAUSE ANALYSIS HAS BEEN REQUESTED OF THE SUPPLIER AND CORRECTIVE ACTIONS WILL BE APPLIED AT THE END OF THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    THE ORIGINAL REPORT STATED ONLY THAT "SALINE LEAKAGE WAS OBSERVED FROM THE FLUSH DEVICE DURING USE." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8888 CUSTOM DEFINED DEVICE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR CK1216Y_ ZP0789MT

    Patients

    Seq Age Sex Outcome Treatment
    1