BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SE PUMP

    MDR report key: 1934172 · Received December 14, 2010

    Report

    Report Number
    2016493-2010-00495
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K043590
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RECEIVED BY CAREFUSION ON (B)(4), 2010 AND IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE ISSUED ONCE THIS IS COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PUMP CAUGHT FIRE AND THAT IT APPEARS THAT THERE WAS FLUID INGRESS AT THE MAINS INLET. NO ADD'L INFO PROVIDED. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP FRN CAREFUSION CORP. 7131 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK