BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMED 960A

    MDR report key: 147135 · Received January 3, 1998

    Report

    Report Number
    147135
    Event Type
    Injury
    Date Received
    January 3, 1998
    Date of Event
    July 31, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ALARIS MEDICAL SYSTEMS ATTN: QUALITY CONTROL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1910 PUMP ALARMED. PUMP TURNED OFF AND RESET RATE TO 41CC/HR. TOTAL VOL TO 100. 1912 & 1920 ACCUCHECKS READ "HIGH" 1940-NOTED TPN BAG DEPLETED TO APPROX 500CC. PT PUT ON BLOW BY O2 AND TAKEN TO PICU TO MONITOR AND DECREASE BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED 960A INFUSION PUMP FRN ALARIS MEDICAL SYSTEMS ATTN: QUALITY CONTROL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Required Intervention