BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1422168 · Received March 19, 2009

    Report

    Report Number
    2016493-2009-00025
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Report Date
    February 9, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH A MALFUNCTION WAS REPORTED BY THE CUSTOMER, WE CANNOT CONFIRM THIS AS THE DEVICE HAS NOT BEEN RETURNED TO US FOR INVESTIGATION. WE ARE WORKING WITH THE CUSTOMER TO MAKE EVERY EFFORT TO OBTAIN EVENT DETAILS AND TO PERFORM AN INVESTIGATION, INCLUDING PERFORMING THE INVESTIGATION ON-SITE IF NECESSARY FOR CUSTOMER CONVENIENCE. IF ADDITIONAL INFO IS RECEIVED OR DEVICE BECOMES AVAILABLE FOR INVESTIGATION, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DATE OF EVENT IS UNK. INITIAL REPORT OF A POSSIBLE UNREGULATED FLOW EVENT; REPORTED BY HOSPITAL THAT NURSE PROGRAMMED THE PUMP FOR 6.3 ML/HR, TUBING WAS LOADED AND THE DOOR WAS SHUT. THE PUMP SEEMED TO BE PUMPING NORMAL. THE NURSE LOOKED AT THE BAG OF FLUID AND THE BAG APPEARED TO BE FREE FLOWING INTO THE PT. THERE WAS NO HARM TO THE PT, NO MEDICAL INTERVENTION. PRODUCT RETURN HAS BEEN REQUESTED INCLUDING ASSOCIATED DISPOSABLE SET AND PC UNIT. SUBSEQUENT ANECDOTAL INFO WAS RECEIVED THAT THE DISPOSABLE SET WAS OBSERVED TO POSSIBLY BE MISLOADED AT THE TIME OF THE INCIDENT, AND THAT THE DEVICE MAY BE DAMAGED IN SOME WAY, POSSIBLY AT THE DOOR HINGE, POSSIBLY WITHIN THE LATCHING MECHANISM, AND THIS DAMAGE MAY HAVE CAUSED THE DEVICE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS SYSTEM PC UNIT, SERIAL NUMBER UNK