BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2013796 · Received February 4, 2011

    Report

    Report Number
    1036844-2011-00041
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 16, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A MALE PATIENT (PT) IN (B)(6). THE CATHETER INSERTION SITES ARE VARIOUS, BOTH NECK AND FEMORAL SITES THAT WERE PLACED IN THE ITU. THE DRUGS/CONCENTRATIONS THAT ARE BEING ADMINISTERED ARE HEPARIN, FLOLAN AND VARIOUS OTHERS. THE ACUTE HD CENTRAL VENOUS CATHETER (CVC) CONTINUED TO CLOT OFF, SO THE CATHETER HAD TO BE REMOVED AND REPLACED. THE DIFFICULTY WAS ENCOUNTERED AT DIFFERENT TIMES, FROM ALMOST IMMEDIATELY AFTER INSERTION TO THE LINE BEING INSITU FOR A LONGER PERIOD OF TIME BEFORE NEEDING TO BE REPLACED. IT WAS REPORTED THAT 7 CATHETERS WERE USED ON THIS PT FROM (B)(6) 2011 TO (B)(6) 2011. THERAPY WAS DELAYED OR INTERRUPTED APPROXIMATELY 8 HRS OR MORE. IT WAS NOTED APART FROM THERAPY BEING DELAYED THERE WERE NO PT COMPLICATIONS REPORTED. THE OUTCOME OF THE PT IS "REMAINS" IN ITU. REFERENCE MDR # 1036844-2011-00040, 1036844-2011-00042, 1036844-2011-00043, 1036844-2011-00044, 1036844-2011-00045, 1036844-2011-00046 FOR THE RELATED EVENTS INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HEPARIN| FLOLAN