BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4 INCH SMALL PATIENT

    MDR report key: 4093109 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00342
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED FAILURE SINCE NO PRODUCT WAS PROVIDED FOR EVAL. IT WAS FOUND DURING TESTING OF SIMILAR PORTS, THAT WHEN THE CAP IS PLACED ON THE LUER TOO SOON AFTER MANUFACTURING. THE GLUE ON THE COMPONENT COULD STILL BE WET CAUSING THE CAP TO BECOME FUSED TO THE LUER. ADDITIONALLY, A REVIEW OF DEVICE HISTORY AND MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO ISSUES FOUND WHICH COULD CONFIRM THE REPORTED ISSUE. IN ORDER TO ADDRESS THE REPORTED ISSUE AND PRESENT ANY ISSUES FROM OCCURRING, THE MANUFACTURING PERSONNEL HAVE BEEN RE-TRAINED ON PROPER MANUFACTURING METHODS WITH SPECIAL ATTENTION GIVEN TO ALLOWING THE GLUE TO DRY BEFORE PLACING THE CAPS ON LUER CONNECTORS. IN ORDER TO ADDRESS THE ISSUE OF THE MISSING CAP, THE DRAWING HAS BEEN CHANGED TO SPECIFY THAT THE CAP MUST BE CHECKED FOR TIGHTNESS PRIOR TO LEAVING THE MANUFACTURING AREA. (B)(4).

    Description of Event or Problem · 1

    THE CABLE LINE CAPS APPEAR TO BE FUSED TO THE LUER. YESTERDAY IT WAS TIGHT OUT COME APART USING 2 CLAMPS. TODAY'S LUER CAME APART USING 2 CLAMPS. NOW A REPLACEMENT IS NEEDED. THE HEMOCONCENTRATOR CAP ON EFFLUENT SIDE TENDS TO BE LOOSE AND TODAY HAS FALLEN OUT AND IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506748 1/4 INCH SMALL PATIENT CARDIOPULMONARY DEVICE DWE DATASCOPE CORP. BO-T 31660 15202-03

    Patients

    Seq Age Sex Outcome Treatment
    1