BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS TWO-LUMEN KTI: 2-

    MDR report key: 911564 · Received March 22, 2007

    Report

    Report Number
    1036844-2007-00021
    Event Type
    Malfunction
    Date Received
    March 22, 2007
    Date of Event
    September 18, 2006
    Report Date
    March 22, 2007
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    k010399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED SAMPLE REVEALED THAT CATHETER SHAFT WAS ATTACHED TO HUB CONNECTION ASSEMBLY. DURING REVIEW, CONNECTOR ASSEMBLY WAS REMOVED FROM CATHETER, & IT WAS NOTED THAT GREEN COMPRESSION SLEEVE WAS NOT LOCATED INSIDE CONNECTOR. INSTRUCTIONS FOR USE FOR CATHETER INCLUDE WARNING TO ENSURE THAT COMPRESSION SLEEVE IS PRESENT WHEN THREADING COMPRESSION CAP ONTO HUB CONNECTION ASSEMBLY TO REDUCE POSSIBILITY OF AIR EMBOLISM, BLOOD LOSS, OR CATHETER SEPARATION. BECAUSE A LOT NUMBER WAS NOT PROVIDED, A DEVICE HISTORY RECORD REVIEW WAS NOT POSSIBLE. A ROOT CAUSE COULD NOT BE DETERMINED AS SEPARATION OF CATHETER WAS UNCONFIRMED. A FOLLOW-UP REPORT WILL BE FILED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED IN 2006, AND WAS USED FOR DIALYSIS THE NEXT DAY, WITHOUT EVENT. THE PATIENT ATTENDED DIALYSIS THREE DAYS LATER, AND THE STAFF WAS UNABLE TO OBTAIN BLOOD FLOW. THE CATHETER HAD BECOME DISCONNECTED, AND THEREFORE IT WAS REMOVED. AN ECHO CARDIOGRAM WAS TAKEN TO CONFIRM THERE WAS NO AIR EMBOLISM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS TWO-LUMEN KTI: 2- CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR DIALYSIS:| CATHETER INSERTION: