BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT CASSETTE FILTERLESS SPIKE

    MDR report key: 2072735 · Received April 7, 2011

    Report

    Report Number
    1722214-2011-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 7, 2011
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN CASSETTE WAS RETURNED FOR AN EVALUATION, IT WAS NOTED THAT THE CASSETTE HAD A WHITE SUBSTANCE ON THE CASSETTE. THE CASSETTE WAS MOUNTED ONTO A KNOWN GOOD PUMP TO TEST. THE SPIKE OF THE CASSETTE WAS CUT OFF AND A MALE LUER WAS GLUED ONTO SO THAT WE COULD RUN BLUE FOOD COLORING THROUGH THE LINE. WHEN THE PUMP WAS ACTIVATED, THE PUMP GAVE A MALFUNCTION ALARM. THE CASSETTE WOULD NOT TURN ON THE PUMP. THE CASSETTE WAS REMOVED FROM THE PUMP. THE CASSETTE WAS DISASSEMBLED AND BLUE FOOD COLORING WAS RAN THROUGH THE LINE. A SMALL LEAK WAS NOTICED WHERE THE C-FLEX TUBING AND PVC TUBING MEET. THE BONDING AREA DOES NOT APPEAR TO HAVE A SUFFICIENT AMOUNT OF GLUE. WE ARE WORKING WITH OUR MANUFACTURING TEAM TO DETERMINE A ROOT CAUSE, CORRECTIVE/PREVENTIVE ACTION. AN UPDATE WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THE PATIENT WENT INTO THE DOCTOR'S OFFICE FOR CHEMOTHERAPY TREATMENT. A CASSETTE (B)(4) WAS PUT ONTO A PATIENT. THE PATIENT WAS THEN SENT HOME FROM THE DOCTOR'S OFFICE TO CONTINUE AND FINISH HIS/HER TREATMENT. DURING THE DRIVE HOME, THE PATIENT NOTICED THE FLUID LEAKING FROM THE CASSETTE. THE PATIENT TURNED AROUND AND WENT BACK TO THE DOCTOR'S OFFICE. THE CASSETTE (B)(4) WAS CHANGED OUT AND THE PATIENT WENT HOME TO COMPLETE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT CASSETTE FILTERLESS SPIKE AMBIT CASSETTE FILTERLESS SPIKE FPA SUMMIT MEDICAL PRODUCTS, INC 220139 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1