BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 1874259 · Received October 14, 2010

    Report

    Report Number
    2016493-2010-00473
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 13, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AS OF 10/14/2010 AND ALL AVAILABLE INFO IS INCLUDED. A THERMAL STRESS EVENT ON THE DEVICE WAS CONFIRMED. THE RIGHT (MALE) INTER UNIT INTERFACE (IUI) CONNECTOR ON THE PCU DEVICE DISPLAYED THERMAL DAMAGE. A RESISTANCE MEASUREMENT FOUND THESE PINS WERE SHORTED. THE NOTED DAMAGED PCU IUI CONNECTOR HAD FLUID RESIDUE AND CORROSION ON THE PINS. THE ASSOCIATED LVP DEVICE ALSO HAD EVIDENCE OF FLUID RESIDUE AROUND THE EXTERIOR SURFACE OF THE INTERFACING FEMALE IUI CONNECTOR AND ALSO ON ITS RIGHT MALE IUI CONNECTOR. THE ROOT CAUSE FOR THE BURNING OF THE IUI CONNECTORS WAS NOT DEFINITIVELY IDENTIFIED, BUT THE EVIDENCE SUGGESTS THAT FLUID CONTAMINATION WAS THE MOST LIKELY CAUSE FOR THE CUSTOMER'S EXPERIENCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INFUSION PUMP CAUGHT FIRE. A STRONG BURNED ELECTRONICS SMELL CAME FROM THE PUMP. REPORTED, THERE WAS AN ARC AND A FLAME COMING FROM THE UNIT SO, THE UNIT WAS UNPLUGGED . NO PT OR STAFF HARM. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, (B)(4)