BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 3043465 · Received March 13, 2013

    Report

    Report Number
    2016493-2013-00150
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, LOGS/DEVICE HAVE NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE LOGS/DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    NO INFO IS AVAILABLE FROM THE CUSTOMER; THE ONLY INFO IS AN ESCALATION E-MAIL FROM TECH SUPPORT, WHICH STATES THAT THE CUSTOMER NEEDS HELP INVESTIGATING AN INCIDENT WITH AN OVERINFUSION; REPORTEDLY THERE WAS AN ADVERSE REACTION WITH THE PT BUT NO DETAILS WERE PROVIDED. TECH SUPPORT ASSISTED WITH EVENT LOG DOWNLOAD, BUT ONLY GOT THE PCU S/N. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106194 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK