BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-O PAIN MANAGEMENT SYSTEM PUMP

    MDR report key: 687483 · Received February 23, 2006

    Report

    Report Number
    MW1038102
    Event Type
    Death
    Date Received
    February 23, 2006
    Date of Event
    November 24, 2005
    Report Date
    February 23, 2006
    Manufacturer
    *
    Product Code
    NEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAD INGUINAL HERNIA REPAIR SURGERY. PT WAS DISCHARGED WITH AN "ON-Q PUMP PAIN MANAGEMENT SYSTEM" PUMP CONTIANING SENSORCAINE 0.5%. PT WAS NOTED BY WIFE TO HAVE MENTAL STATUS CHANGES THE NIGHT AFTER THE PROCEDURE. THE WIFE CALLED EMS TO THE HOUSE THE NEXT DAY BUT THE PT REFUSED TO GO TO THE ED. WIFE STATED PT WAS ACTING INAPPROPRIATELY. PT DID FINALLY AGREE TO GO TO THE ED. PT PRESENTED TO THE ED WITH COMPLAINTS OF LOWER BACK PAIN AND UPON EXAMN HAD BRADYCARDIA. DURING THE ED EVALUATION, PT BECAME DIAPHORETIC AND SOB. PT ADMITTED TO ICU AND WAS MINIMALLY INTERACTIVE AND LETHARGIC. THE ON-Q PUMP WAS PULLED BY SURGERY. PT EXPERIENCED PERSISTENT BRADYCARDIA AFTER SEVERAL MEDICINE INTERVENTIONS. PT WAS INTUBATED AND NG TUBE WAS PLACED. NURSES UNABLE TO OBTAIN BLOOD PRESSURE OR PALPATE PULSES. PT DIED AT 1157.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-O PAIN MANAGEMENT SYSTEM PUMP ON-O PAIN MANAGEMENT SYSTEM PUMP NEB * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death