BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4231885 · Received October 17, 2014

    Report

    Report Number
    2016493-2014-00495
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SECONDARY INFUSION FASTER THAN EXPECTED. INFUSION OF POTASSIUM 10 MEQ PROGRAMMED VIA DEVICE AT 100 MG/HR. PRIOR TO LEAVING BEDSIDE RN OBSERVED FAST DROPS THROUGH DRIP CHAMBER AND STOPPED INFUSION IMMEDIATELY. RN TRIED SEVERAL DIFFERENT PUMP MODULES (ONLY ONE DEVICE WAS SEQUESTERED) AND SAME RESULT WAS OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT/EVENT DETAILS WERE PROVIDED. MANUFACTURER'S REPORT NUMBER: 2016493-2014-00495. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662407 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| LOT UNK| SECONDARY ADMINISTRATION SET, MODEL 10016073,| ALARIS PUMP MODULE TUBING, MODEL 11607704, LOT UNK