BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTANT FLOW IMPLANTABLE PUMP

    MDR report key: 39760 · Received February 25, 1996

    Report

    Report Number
    1221409-1996-00001
    Event Type
    Injury
    Date Received
    February 25, 1996
    Report Date
    October 28, 1996
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. OUR EVALUATION WASN'T ABLE TO DUPLICATE THE CUSTOMER'S PROBLEM. HOWEVER, WE BELIEVE THAT THE PROBLEM IS CONSISTENT WITH CATHETER KINKING. A KINKED CATHETER, AND PERHAPS PRECIPITATES FROM INCOMPATIBLE DRUG BOLUS, THROMBUS OR SHEATH FORMATION AT OR AROUND THE TIP MAY ALLOW A BOLUS FLUSH BUT INTERFERE WITH THE PUMP FLOW.

    Description of Event or Problem · 1

    ON 10/28/96 AN INCIDENT OCCURRED INVOLVING A PORT. APPROX. 3 WEEKS POST-PLACEMENT IT WAS NOTED THE CATHETER HAD DISCONNECTED FROM THE PORT AND MIGRATED TO THE PULMONARY ARTERY. RETRIEVAL OF THE CATHETER UTILIZING A SNARE WAS UNEVENTFUL. ANOTHER PORT WAS NOT PLACED AND THE PT'S CONDITION IS GOOD. CO'S PRELIMINARY INVESTIGATION SUGGESTS INAPPROPRIATE CATHETER CONNECTION DURING PLACEMENT MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE IS CURRENTLY BEING EVALUATED. UPON COMPLETION OF THE ENGINEERING EVAL A SUPPLEMENTAL REPORT WILL BE FORWARDED UNDER 1221409-1996-00001. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "IMPROPER ASSEMBLY MAY RESULT IN CATHETER DAMAGE, LEAKAGE OR POSSIBLE DISCONNECTION. WHEN PROPERLY ASSEMBLED, THE PORT'S LOCKING COLLAR SHOULD BE FULLY ENGAGED INTO THE OUTLET TUBE GROOVE AND CATHETER SHOULD BE VISIBLE THROUGH THE LOCKING COLLAR SLOTS." NO PT INFO WAS AVAILABLE DUE TO PT CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTANT FLOW IMPLANTABLE PUMP Implant IMPLANTABLE PUMP LKK ARROW INTERNATIONAL, INC. NA 9605

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention