BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2990178 · Received February 6, 2013

    Report

    Report Number
    2016493-2013-00091
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOG REVIEW PENDING. THE DATA SET AND LOGS HAVE BEEN RECEIVED AND AN EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PHARMACIST REQUESTED AN EVENT LOG REVIEW OF A TPN INFUSION DUE TO THE NURSE¿S REPORT THAT IT DID NOT INFUSE. THE TPN WAS PROGRAMMED AS A PRIMARY INFUSION ON (B)(6) 2013 AROUND 8:28 PM WITH A VOLUME OF 1512 ML AT A RATE OF 63 ML/HR TO INFUSE OVER 24 HOURS. NONE OF THE SUBSEQUENT SHIFTS REPORTED ANY ALARMS OR ALERTS, AND WHEN IT WAS TIME TO HANG THE NEXT BAG ON THE EVENING OF (B)(6) 2013, THERE WAS STILL 1500 ML LEFT IN THE PREVIOUS BAG. THE PATIENT WAS NPO AND APPARENTLY RECEIVED NO TPN FOR THE 24 HOUR PERIOD. THERE WAS NO REPORT OF PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD¿L PATIENT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50312 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR ALARIS PC UNIT: SN (B)(4)| MODEL/LOT NUMBER UNK| ALARIS PUMP MODULE ADMINISTRATION SET: