BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2251683 · Received August 31, 2011

    Report

    Report Number
    2016493-2011-00493
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    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). THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    CUSTOMER SENT DEVICE TO SERVICE DEPT FOR REPAIR BECAUSE OF UNREGULATED FLOW. BIOMED CONFIRMED THAT DEVICE FAILED DURING DIAGNOSTIC TESTING AND THERE AS NO PT INVOLVEMENT. SERVICE DEPOT REPORTED THAT THE UNIT WAS RECEIVED MISSING THE PLATEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA