BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICE

    MDR report key: 24725 · Received July 24, 1995

    Report

    Report Number
    24725
    Event Type
    Injury
    Date Received
    July 24, 1995
    Date of Event
    June 6, 1995
    Report Date
    June 15, 1995
    Manufacturer
    AVI, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 500 ML OF 25,000 U HEPARIN SOLUTION OVER A 2 HOUR 10 MINUTE PERIOD. THE INFUSION WAS CONTROLLED BY A MECHANICAL DEVICE. ON 6/9/95, IN PRESENCE OF THE MFR'S REPRESENTATIVES, THE CO PUMP WAS OPENED AND THERE WAS A DISCONNECT OF THE BLACK WIRE FROM THE UPPER SLIDE CONNECTOR ON THE DOORS MICRO SWITCH. THIS SWITCH IS NORMALLY "CLOSED" AND IS "OPEN" WHEN THE DOOR LOCK IS PROPERLY TIGHTENED. THE MISSING WIRE CONNECTION RESULTED IN A DOOR LOCK "OK" CONDITION REGARDLESS OF THE POSITION OF THE DOOR LOCK. THE RESULT WAS AN ALARM MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION DEVICE INFUSION DEVICE FRN AVI, INC. 400A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention