BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDSLAB CLOSED INJECTATE DELIVERY SYSTEM

    MDR report key: 3920013 · Received July 8, 2014

    Report

    Report Number
    2015691-2014-01552
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRB
    PMA / PMN Number
    K811399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CO-SET SYRINGE WAS RECEIVED FOR EVALUATION. THE FLOW-THROUGH HOUSING WHICH INCLUDES THE CHECK-VALVE AND TUBING COIL WERE NOT RETURNED. THE VISUAL EXAMINATION REVEALED THAT THE TIP OF THE SYRINGE WAS INTACT. THERE WAS NO DAMAGE OBSERVED. THE SYRINGE WAS TESTED WITH A CO-SET FLOW-THROUGH HOUSING AND A SWAN-GANZ CATHETER FROM THE PRODUCT LAB. THERE WAS NO LEAKAGE OBSERVED FROM THE SYRINGE OR FROM THE SYRINGE TO THE FLOW-THROUGH HOUSING CONNECTION AFTER MULTIPLE CYCLES OF ASPIRATION AND INJECTION. THE IFU RECOMMENDS TO CHECK ALL CONNECTIONS TO ENSURE THEY ARE SECURELY CONNECTED DURING USE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION. THE COMPLAINT COULD NOT BE CONFIRMED DURING EVALUATION. THERE IS NO INDICATION OF A MANUFACTURING DEFECT THAT WAS NOTED DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CO-SET SYRINGE WAS FOUND TO BE LEAKING INTERIORLY WHEN IN USE WITH THE PATIENT. THE CLINICIAN OBSERVED FAULTY CARDIAC OUTPUT MEASUREMENTS WHEN THE LEAKAGE WAS DISCOVERED. WHEN DISCOVERED THE CARDIAC OUTPUT MEASUREMENTS CO/CI WERE LOW. EARLIER THE MEASUREMENTS WERE WITHIN NORMAL RANGE. WHEN THE FAULTY MEASUREMENTS WERE DISCOVERED, A MIXED VENOUS BLOOD GAS WAS FOUND TO BE WITHIN NORMAL LIMITS; THEREFORE, NOT COINCIDING WITH THE LOW CO/CI MEASUREMENTS THAT WERE OBSERVED. THERE WAS NO COMPLICATIONS OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396486 EDSLAB CLOSED INJECTATE DELIVERY SYSTEM CO-SET+ CLOSED INJECTATE DELIVERY SYSTEM FOR COLD INJECTATE KRB EDWARDS LIFESCIENCES DR 93610 59692323

    Patients

    Seq Age Sex Outcome Treatment
    1