BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2803025 · Received October 17, 2012

    Report

    Report Number
    9616066-2012-00740
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD IT BE RECEIVED FOR EVAL. THE CUSTOMER WAS PROVIDED WITH INFO RELATED TO PROPER TECHNIQUE AND INFORMED THAT THE FILTER NEEDS TO BE KEPT AT OR NEAR HEART LEVEL TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT DETAILS WERE REPORTED: THE PT WAS BEING WEIGHED ON A BED SCALE AND THE LINES WERE HELD ABOVE THE LEVEL OF THE CORDIS CATHETER SO THEY WOULD NOT BE WEIGHED. THE PT DEVELOPED TACHYCARDIA, HYPERTENSION, AND ECTOPY. THIS PT WAS ON A DOPAMINE DRIP ON AN ALARIS PUMP. THE CUSTOMER IS QUESTIONING IF THE PT RECEIVED A BOLUS WHILE THE LINES WERE BEING HELD ABOVE THE LEVEL OF THE CORDIS. ALTHOUGH REQUESTED, ADDITIONAL PT/EVENT INFO HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CORDIS CATHETER: MODEL/LOT# UNK| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN UNK