BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVI

    MDR report key: 156854 · Received March 17, 1998

    Report

    Report Number
    MW1013184
    Event Type
    Malfunction
    Date Received
    March 17, 1998
    Date of Event
    January 30, 1998
    Report Date
    February 26, 1998
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN AVI 840 DUAL CHANNEL IV PUMP GAVE A LOW BATTERY INDICATION WHILE IN TRANSPORT TO ANOTHER MED FACILITY. THE PUMP HAD BEEN CONTINUOUSLY CHARGED. IT WAS PLUGGED INTO THE INVERTER IN THE AMBULANCE. UPON TRANSFER OF THE PT FROM THE AMBULANCE TO THE ICU, THE PUMP LOST POWER. THE PT WAS WITHOUT DOPAMINE AND LACTATED RINGERS DURING THE TRANSFER. THIS COULD HAVE BEEN A DISASTROUS SITUATION. THE EQUIPMENT WAS DELIVERED TO THE MED MAINTENANCE DEPT ON 29 JAN 98. THE SETTINGS OF THE PUMP WERE NOTED AND THE UNIT WAS CHECKED FOR PHYSICAL DAMAGE. A REVIEW OF THE MAINTENANCE HISTORY WAS CONDUCTED, WITH NO PROBLEMS DOCUMENTED. THE LAST PREVENTIVE MAINTENANCE/CALIBRATION INSPECTION WAS PERFORMED IN MARCH 97 WITH NO PROBLEMS NOTED. A REVIEW OF THE MFRS LITERATURE REVEALED A NEW, FULLY CHARGED BATTERY, WITH DUAL CHANNEL USE SHOULD OPERATE 4 HRS BEFORE THE PRIMARY ALARM SOUNDS. THE SECONDARY LOW BATTERY ALARM SHOULD THEN SOUND 1/2 HR BEFORE DISABLING INFUSION. THE EQUIPMENT WAS CHARGED AND TESTED. IT INFUSED FOR ONLY 28 MINS BEFORE SOUNDING THE PRIMARY BATTERY ALARM. WITHIN 30 SECONDS THE SECONDARY ALARM SOUNDED DISABLING INFUSION CAPABILITY. THE PROBABLE CAUSE OF THIS MALFUNCTION WAS A DETERIORATED BATTERY. AS A RESULT OF THIS THE MAINTENANCE DEPT WILL SHORTEN THE PM CYCLE ON THESE PUMPS FROM 12 TO 6 MOS. BATTERY REPLACEMENT DATES WILL BE DOCUMENTED IN THE EQUIPMENT RECORD, AND ALL AVI PUMPS WILL BE PULLED FROM SVC AND CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI INFUSION PUMP FRN 3M HEALTH CARE AVI 840 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other