BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3851395 · Received March 26, 2014

    Report

    Report Number
    2016493-2014-00132
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    May 6, 2013
    Report Date
    February 24, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT OF AN OVERINFUSION COULD NOT BE CONFIRMED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG INDICATES THAT THE PUMP MODULE IN QUESTION HAD BEEN RUNNING A BUMETANIDE DRIP INFUSION, WITH THE CONCENTRATION PROGRAMMED AT 0.25 MG/ML, FOR SEVERAL DAYS WITH THE FLOW RATE CALCULATED AT 8 ML/HR. ON (B)(6) 2013 AT 9:02 AM THE USER ACCESSED THE PUMP MODULE AND PRESSED THE SETUP SOFTKEY. THE USER THEN CHANGED THE DILUENT VOLUME FROM 100 MLS TO 180 MLS WHICH CHANGED THE CONCENTRATION TO 0.139 MG/ML. WITH THE DOSE SET AT 2 MG/H THE FLOW RATE WAS RECALCULATED AT 14.4 ML/HR. LATER THAT DAY, AT 3:37 PM, THE CONCENTRATION WAS PROGRAMMED BACK TO THE ORIGINAL 0.25 MG/ML AND THE FLOW RATE RECALCULATED TO 8 ML/HR. TESTING AND INSPECTION OF THE PUMP MODULE FOUND IT TO BE IN GOOD WORKING CONDITION AND DELIVERING FLUID WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE CUSTOMER'S REPORT IS BELIEVED TO BE USER PROGRAMMING. NO FAULT WAS FOUND WITH THE PUMP MODULE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER-INFUSION. THE USER FOUND THE RATE HIGHER THAN WHAT WAS INITIALLY PROGRAMMED. NO PATIENT HARM OR MEDICAL INTERVENTION WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176880 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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