BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTANT FLOW IMPLANTABLE PUMP

    MDR report key: 371382 · Received January 11, 2002

    Report

    Report Number
    1221409-2002-00002
    Event Type
    Death
    Date Received
    January 11, 2002
    Date of Event
    December 4, 2001
    Report Date
    January 8, 2002
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    LKK
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED TWO DAYS AFTER SUFFERING ANOXIC BRAIN INJURY WHICH OCCURRED FOLLOWING PAIN MEDICATION BOLUS VIA THE IMPLANTED INFUSION PUMP PATHWAY. THE PT WAS RESUSCITATED BUT LIFE SUPPORT WAS WITHDRAWN TWO DAYS LATER. THE HOSP IS NOT ATTRIBUTING THE DEATH TO A PUMP FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR MORPHINE.