BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT PUMP CASSETTE

    MDR report key: 744076 · Received June 22, 2005

    Report

    Report Number
    1722214-2005-00006
    Event Type
    Malfunction
    Date Received
    June 22, 2005
    Report Date
    May 27, 2005
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JANUARY 2005, A REVIEW OF THE LABELING WAS CONDUCTED AND FOUND TO BE ADEQUATE. THE MANUAL INDICATES WHICH TUBING SET IS ATTACHED TO THE PATIENT AND WHICH SET IS ATTACHED TO TBE MEDIBAG. THE CASSETTE HAS ICONS THAT SHOW WHICH TUBING SET IS TO THE MEDIBAG AND PATIENT. AN ADDITIONAL LABEL IS ALSO PRESENT ON THE PATIENT TUBING SET IDENTIFYING IT AS THE PATIENT SIDE. IT WAS DECIDED TO FURTHER STRENGTH THE LABELING WITH AN ADDITIONAL LABEL NEAR THE LUER ON THE PATIENT SIDE OF THE TUBING SET. THIS LOT WAS MANUFACTURED PRIOR TO THE ADDITION OF THE SECOND LABEL ON THE PATIENT TUBING SET. A TRAINING CD HAS BEEN SENT TO THE DISTRIBUTOR TO BE USED IN THE TRAINING OF SCRUB TECH'S.

    Description of Event or Problem · 1

    THE MABIT CASSETTE WAS HOOKED UP BACKWARDS; THE LONG LINE OF THE AMBIT CASSETTE WAS HOOKED UP TO THE MEDIBAG AND THE SHORT LINE TO THE WOUND CATHETER. THE PATIENT REPORTED TO THE DISTRUBUTOR THAT THERE WAS BLOOD IN THE MED LINES FROM THE PUMP. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS ASSOCIATED WITH HIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT PUMP CASSETTE AMBULATORY INFUSION PUMP CASSETTE FRN SORENSON MEDICAL, INC. NA 308117

    Patients

    Seq Age Sex Outcome Treatment
    1