BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 3092238 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19990
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE COMPLAINT UNIT IDENTIFIED A DIFFERENT FAILURE THAN THE ONE REPORTED. WE RECEIVED A SINGLE FLOTHRU DPT KIT IV SET AND ATTACHED MERIT FLUSH DEVICE. THERE WAS NO VISIBLE BLOOD FOUND FROM THE KIT. IN ADDITION, THERE WAS NO LEAKAGE FOUND IN THE KIT DURING LEAK TESTING. ALL CONNECTIONS APPEARED TIGHT. ALTHOUGH WE DID NOT CONFIRM LEAKAGE, WE DID CONFIRM THAT THE FLOW RATE OF THE MERIT FLUSH DEVICE DID NOT MEET IFU SPECIFICATIONS; FLOW MEASURED AN AVERAGE OF 116.5ML/HR (ALLOWABLE SPECIFICATION IS 2-4ML/HR). IT APPEARED THAT THE ONE END OF SILICONE HOUSING DID NOT TOUCH THE BASE OF MALE CONNECTOR POCKET AND THIS AFFECTED THE FLOW RATE. THE COMPLAINT WAS RELATED TO A MANUFACTURING NON-CONFORMANCE OF THE MERIT SUPPLIED DEVICE. ROOT CAUSE ANALYSIS AND IMPLEMENTATION OF ANY NECESSARY CORRECTIVE ACTIONS HAS BEEN REQUESTED OF THE SUPPLIER.IN ADDITION, THE MANUFACTURING PLANT IMPLEMENTED A FLOW TEST AT INCOMING AREA. A SUPPLEMENTAL WILL BE FORTHCOMING WITH THE DEVICE HISTORY RECORD RESULTS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "HEPARINIZED SALINE LEAKAGE WAS OBSERVED NEAR THE STAND ALONE MERIT FLUSH DEVICE BEFORE USE." IT COULD NOT BE CONFIRMED WHETHER THERE WAS ANY DAMAGE TO THE FLUSH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194109 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VO3508TSPL01 ZU1082MT

    Patients

    Seq Age Sex Outcome Treatment
    1