BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3944166 · Received May 7, 2014

    Report

    Report Number
    2016493-2014-00238
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES RECEIVED, LOG REVIEW ONLY. THE DEVICE LOGS HAS BEEN RECEIVED AND THE INVESTIGATION IS IN-PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IV NORMAL SALINE, 250ML BAG WAS HUNG AT 01:00 ON (B)(6) 2014 AND SET TO INFUSE A VTBI OF 240ML AT 10ML/H AS A PRIMARY INFUSION. THE BAG WAS FOUND EMPTY AT 05:30. THE PRIMARY BAG HAD BEEN SUSPENDED ON A HANGER, SO IT IS PRESUMED THAT THE PATIENT MAY HAVE RECEIVED ONE OR MORE SECONDARY MEDICATIONS DURING THE USE OF THIS PRIMARY SET. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274846 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL 2426-0007| ALARIS PC UNIT: SN (B)(4)| LOT UNK