BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3636677 · Received December 19, 2013

    Report

    Report Number
    2016493-2013-00538
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 26, 2013
    Report Date
    December 10, 2013
    Manufacturer
    CAREFUSION CORPORATE
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INFUSION OF 230 ML AT RATE OF 7.5 ML/HR WAS ACCURATELY PROGRAMMED, BUT TOOK LESS TIME THAN EXPECTED. THE MEDICATION REPORTED TO BE NEOSYNEPHRINE. THE EVENT OCCURRED ON CARDIO-PULMONARY ICU UNIT. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667814 ALARIS PUMP MODULE FRN CAREFUSION CORPORATE 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS PC UNIT: SN (B)(4)| MODEL/LOT # UNK