BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED GEMINI PC-2

    MDR report key: 100934 · Received June 23, 1997

    Report

    Report Number
    2021283-1997-00035
    Event Type
    Malfunction
    Date Received
    June 23, 1997
    Date of Event
    April 12, 1997
    Manufacturer
    IMED CORP.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS EVALUATED BY THE MFR. THE ERROR LOG WAS CHECKED AND FOUND TO BE EMPTY. BOTH CHANNELS WERE OPERATED FOR SEVERAL HRS, BEGINNING WITH VTBI OF 9999ML.; THE RATES WERE KEPT THE SAME AS THE STORED INFUSION DATA. THE VTBI DISPLAY WAS CHECKED AT 96, 120, 144, AND 168 HRS AND THE DISPLAY READ AS EXPECTED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. THE INSTRUMENT IS DESIGNED TO MEET THE REQUIREMENTS OF HEW/FDA MDS-201-0004 ESTABLISHED FROR ELECTRIC FIELD, MAGNETIC FIELD AND TRANSIENT SUSCEPTIBILITY. CORRECTIONS WERE MADE TO SECTIONS D-6 AND 9.

    Description of Event or Problem · 1

    HOSPITAL ADVISED THIS PUMP WAS INVOLVED IN AN INCIDENT OF SPONTANEOUS SECONDARY INFUSION VTBI CHANGE, SUPPORTED BY A BURETTE AUDIT AND BIOMEDICAL OBSERVATION. THERE WERE NO PT CONSEQUENCES. NO ADD'L PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED GEMINI PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER FRN IMED CORP. 1320 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR