BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1892861 · Received November 3, 2010

    Report

    Report Number
    2016493-2010-00482
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    FACILITY BIOMED REPORTED THAT WHILE A PATIENT WAS ALREADY BEING RESUSCITATED, THE DEVICE SMOKED AND SPARKED FROM THE OPEN RIGHT IUI CONNECTOR. THE NURSE STATED THE PATIENT WAS ON MULTIPLE DRIPS AND WHEN SHE ATTEMPTED TO CONNECT A THIRD CHANNEL, A SMALL BURST OF FLAMES CAME OUT OF ONE OF THE CHANNELS. THE SCREEN THEN WENT BLANK AND SMOKE CAME OUT OF ALL CHANNELS. WHEN THE USERS UNPLUGGED THE DEVICE AND TOOK IT OUT OF THE ROOM, IT STOPPED SMOKING. THE BIOMED STATED SEVERAL PINS OF THE IUI HAVE MELTED AWAY WITH AN APPROXIMATELY 1/4 INCH BURNED AREA. THERE WAS A POWER OUTAGE DURING THE SAME SHIFT, BUT HE DOES NOT THINK IT OCCURRED AT THE SAME TIME OR WAS ASSOCIATED WITH THE EVENT. THERE WAS NO HARM TO THE PATIENT OR STAFF. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 2 ALARIS PUMP MODULES, SERIAL NUMBERS UNKNOWN| ALARIS PC UNIT, SERIAL NUMBER UNKNOWN