BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 4188549 · Received October 21, 2014

    Report

    Report Number
    2015691-2014-02473
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    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

    WORK INSTRUCTION FOR ¿CRITICAL ASSEMBLY OPERATION¿ (B)(4) SHALL BE PREPARED. THE BONDING OF Z-SITE WITH PRESSURE TUBE SHALL BE INCLUDED IN THIS WORK INSTRUCTION, MORE DETAILS OF ASSEMBLY SHALL BE DEFINED AS FOLLOWS: -AFTER APPLYING OF GLUING SOLVENT ON THE TUBE BEING GLUE, THE TUBE HAS TO BE INSERTED INTO THE GLUING PART OF Z-SITE AND SLOWLY TWIST OR TURN AROUND TO SPREAD THE GLUING SOLVENT THROUGHOUT THE GLUING PART. ALL RELATED WHO HAS BEEN ASSIGNED TO PERFORM THE GLUING OF Z-SITE AND TUBE SHALL BE ADDITIONAL TRAINED ON THIS WORK INSTRUCTION: (B)(4) AND QUALIFIED ON THE GLUING PROCESS OF Z-SITE AND TUBE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF RELEASE. ONE Z-SITE WITH PRESSURE TUBING WAS RECEIVED FOR EVALUATION. THE PRESSURE TUBING WHICH WAS CONNECTED TO THREE-WAY STOPCOCK WAS DETACHED FROM THE SOLVENT BOND JOINT WITH THE Z-SITE. INDICATION OF BONDING SOLVENT WAS VISIBLE AT BOTH TUBING AND Z-SITE OF THE BOND AREAS. THE TUBING DETACHMENT OCCURRED ON PATIENT SIDE OF THE KIT. INVESTIGATION PENDING AND SUPPLEMENTAL REPORT WITH RESULTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE TUBING CONNECTED TO THE Z-SITE DETACHED AND LED TO BLOOD LEAKAGE DURING AN OPERATION. THE DETACHED TUBING WAS NOTICED IMMEDIATELY SO THE AMOUNT OF BLOOD LEAKAGE WAS SMALL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667473 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VO3803TSB02 EH1237MT

    Patients

    Seq Age Sex Outcome Treatment
    1