BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1974897 · Received January 26, 2011

    Report

    Report Number
    9616066-2011-00020
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 5, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 01/26/2011. (B)(4). PT WAS MIDDLE AGED ADULT. SET ORIGINALLY REPORTED TO BE MODEL 10015048, BUT SET RECEIVED WAS MODEL 2200-0500. SET WAS RECEIVED FOR INVESTIGATION IN 2 PIECES, ATTACHED TO AN EMPTY BAG OF KCL WITH A LABEL STATING TO INFUSE AT 21 ML/HR. A NOTE ATTACHED STATED "HUB WAS CUT OFF." A SEPARATION WAS CONFIRMED, HOWEVER, IT WAS NOTED TO BE AT THE UPPER FITMENT, NOT THE LOWER FITMENT. THE SILICONE WAS OBSERVED TO BE COMPLETELY TORN AWAY FROM THE SET JUST AFTER THE O RING ON THE UPPER FITMENT. CRUSH MARKS WERE NOTED ON THE UPPER FITMENT. THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SET HAD BEEN PRIMED WITHOUT DIFFICULTY AND WAS LATER NOTED DURING A CHEMO INFUSION (RATE 75 ML/HR) TO BE SEPARATED "WHERE THE TUBING CONNECTS ABOVE THE SLIDE CLAMP," PRESUMED TO INDICATE THE JUNCTION OF THE SILICONE SEGMENT TO THE LOWER FITMENT. THE NURSE NOTED FLUID LEAKING OUT OF THE PUMP, OPENED THE DOOR, AND SAW THE SET SEPARATED. NO PATIENT OR STAFF HARM WAS REPORTED. NO ADD'L PT OR EVENT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2200-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS PC UNIT: SERIAL NUMBER UNK| ALARIS PUMP MODULE: SERIAL NUMBER UNK