BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2564826 · Received April 25, 2012

    Report

    Report Number
    2016493-2012-00200
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    November 22, 2011
    Report Date
    April 4, 2012
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REQUESTED A LOT REVIEW TO INVESTIGATE A POSSIBLE UNDER INFUSION OF NORMAL SALINE. THE PCU EVENT LOG SHOWS THAT OF 0.9% NORMAL SALINE WAS PROGRAMMED ON (B)(6) 2011 AT 1:53 PM. THE INFUSION WAS PROGRAMMED TO RUN AT A RATE OF 999ML/HR FOR 1 HOUR. THE INFUSION COMPLETED AT 2:29 PM, AND 999.014ML WAS RECORDED AS BEING DELIVERED. BETWEEN 3:01 PM AND 3:14 PM, THE USER CHANGES THE RATE AND VTBI, INFUSING AN ADD¿L 115.116ML. THE PUMP MODULE WAS THEN SELECTED OFF AT 3:16 PM. THE TOTAL VOLUME THAT WAS RECORDED AS INFUSED WAS 1114.87ML. NO PROGRAMMING ERRORS WERE OBSERVED. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF AN UNDERINFUSION OF 0.9% NORMAL SALINE COULD NOT BE DEFINITIVELY DETERMINED FROM THE PCU EVENT LOT REVIEW ALONE AND NO DEVICES WERE RETURNED.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REQUESTED ASSISTANCE WITH AN EVENT LOG REVIEW. THE BIOMED HAD LIMITED EVENT INFO OF A NORMAL SALINE BOLUS OVER 1 HOUR; 200 ML REMAINING IN BAG AS NOTED ON EQUIPMENT TAG ON PUMP. THE EQUIPMENT TAG PROVIDED READS ¿INFUSED NS BOLUS AT 999 ML/HR, PER MACHINE, IV INFUSED 1000 MLS, HOWEVER ABOUT 800 MLS INFUSED¿. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD¿L PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

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