BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVI 3M IV INFUSION PUMPR

    MDR report key: 107177 · Received July 17, 1997

    Report

    Report Number
    2183161-1997-00018
    Event Type
    Other
    Date Received
    July 17, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 25, 1997
    Manufacturer
    GRASEBY MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THEY HAD CONFUSED THE MODEL 270 IV PUMP WITH THE MODEL 275 IV PUMP AND A CHILD WAS INFUSED WITH A QUANTITY 10 TIMES MORE THAN SHOULD HAVE. PT WAS ADMITTED TO THE PEDIATRIC INTENSIVE CARE DEPARTMENT FOR A FEW DAYS, THERE IS NO REPORT OF DEATH OR SERIOUS INJURY. THE MODEL 275 IS A MICRO INFUSION PUMP THAT HAS A FLUID DELIVERY RATE OF 0.1 TO 99.9 ML/HR AND IS IDENTIFIED BY MODEL NUMBER, GREEN LABELS ON HANDLE AND CONTROL KEYPAD, AND DECIMAL POINT IN NUMERICAL DISPLAYS. THE MODEL 270 HAS A FLUID DELIVERY RATE OF 1 TO 999 ML/HR AND IS IDENTIFIED BY MODEL NUMBER, BLUE LABELS ON HANDLE AND CONTROL KEYPAD, AND NO DECIMAL POINT ON NUMERICAL DISPLAYS. CONFUSION WAS A RESULT OF THE HOSPITAL IDENTIFYING THE DEVICE BY THE REAR CASE COLOR, BOTH BEING GREY. MODEL 275 DEVICES MFG PRIOR TO 11/93 HAD A GREEN REAR CASE. THIS IS THE ONLY REPORTED CONCERN AS A RESULT OF CASE COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 3M IV INFUSION PUMPR IV INFUSION PUMP FRN GRASEBY MEDICAL, INC. 270 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R IV ADMINISTRATION SET