BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDFUSION

    MDR report key: 1691085 · Received April 26, 2010

    Report

    Report Number
    1691085
    Event Type
    Death
    Date Received
    April 26, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 26, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WITH RESPIRATORY DISTRESS SYNDROME, POSSIBLE SEPSIS, RENAL FAILURE, ANEMIA AND INTRA-VENTRICULAR HEMORRHAGE RECEIVED AN UNINTENDED BOLUS OF LIPIDS VIA A MEDICATION SYRINGE PUMP. THE PATIENT WAS ORDERED TO RECEIVE 0.38ML/HR OF LIPIDS BUT RECEIVED 6.3ML OVER A ONE AND A HALF HOUR PERIOD. THE FOLLOWING DAY THE PATIENT EXPIRED. DEATH CERTIFICATE REFLECTS THE CAUSE OF DEATH TO BE INTRA-VENTRICULAR HEMORRHAGE. FAMILY DECLINED AUTOPSY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SYRINGE PUMP HAD A HISTORY OF PLUNGER FAILURE IN 2009 WHICH WAS REPORTED REPAIRED BY THE MANUFACTURER. THE PUMP HAS BEEN IN USE SINCE THE REPAIR AND RETURN WITHOUT ANY ADDITIONAL REPORTED ISSUES REGARDING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION SYRINGE PUMP FRN SMITHS MEDICAL 2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death