BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT CASSETTE FILTER SPIKE

    MDR report key: 1082324 · Received July 29, 2008

    Report

    Report Number
    1722214-2008-00006
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 24, 2008
    Manufacturer
    SORENSON MEDICAL PRODUCTS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS TWO CASSETTE LEAKS REPORTED. BOTH FROM THE SAME LOT NUMBER. ONE OF THE CASSETTES WAS DISCARDED. ONE UNIT WAS RETURNED ON 07/08/2008. THE UNIT WAS TESTED. DURING THE EVALUATION IT WAS NOTED THAT THE CASSETTE DID IN FACT LEAK. THE CASSETTE WAS DISSEMBLED TO DETERMINE WHERE THE LEAK WAS COMING FROM. IT WAS DETERMINED THAT THE C-FLEX TUBING WAS WEDGED UNDER THE GEAR ROLLERS. WITH THE POSITION OF THE C-FLEX TUBING BEING UNDER THE GEAR ROLLERS; THIS OVER TIME WILL CAUSE WEAR AND TEARING TO THE TUBING. ALSO RETURNED WITH THE ONE CASSETTE IN QUESTION WAS TWO ADDITIONAL CASSETTES FROM THE SAME LOT NUMBER. THESE TWO WERE RETURNED UNUSED AND IN UNOPENED POUCHES. THE TWO CASSETTES WERE TESTED AND FOUND TO MEET THE MANUFACTURING STANDARD. SORENSON MEDICAL HAS DETERMINED THAT THIS IS A TRAINING ISSUE WITH ASSEMBLY. A STEP OF ROTATING THE ROLLER ASSEMBLY ONCE THE C-FLEX HAD BEEN SET IN PLACE AND ONE FULL REVOLUTION WAS ADDED TO THE WORK INSTRUCTION. TRAINING FOR INCORRECT PLACEMENT OF C-FLEX HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SENT HOME WITH A 150 CC INFUSION BAG SET TO RUN FOR 46 HOURS (DATE 2008). WHEN PATIENT RETURNED WHITE RESIDUE WAS NOTICED IN THE FANNY PACK. PRODUCT WAS INSPECTED FOR LEAKS. NO LEAK NOTED. PATIENT WAS SENT HOME THE SECOND TIME (NEXT DAY) WITH A NEW INFUSION BAG, AND CASSETTE. PATIENT RETURNED IN THE NEXT DAY, AND REPORTED THAT THE CASSETTE WAS LEAKING. REPORTED TWO LEAKING CASSETTES. ONLY ONE CASSETTE WILL BE RETURNED FOR EVALUATION. THE OTHER WAS DISCARDED. NO PATIENT INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT CASSETTE FILTER SPIKE AMBIT CASSETTE FILTER SPIKE FPA SORENSON MEDICAL PRODUCTS, INC. 220140 D803119

    Patients

    Seq Age Sex Outcome Treatment
    1