BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2251663 · Received August 10, 2011

    Report

    Report Number
    2016493-2011-00460
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 22, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED OVER INFUSION OF THE DRUG HEPARIN WAS CONFIRMED AND FOUND TO BE THE RESULT OF USER PROGRAMMING ERROR. A USER HAD REPROGRAMMED THE DOSE ON (B)(6) 2011 AT 9:30PM TO 2550 UNITS/HOUR AFTER THE PUMP MODULE COMPLETED A PRIOR INFUSION OF HEPARIN AT THE RATE OF 2250 UNITS/HOUR (THE INTENDED DOSING RATE). THE USER ALLOWED THE INFUSION TO CONTINUE AT THE DOSING RATE OF 2550 UNITS/HOUR UNTIL (B)(6) 2011 AT 1:50AM WHEN THE USER RETURNED THE DOSING RATE TO 2250 UNIT/HOUR. THE USER DID RECEIVE A SOFT GUARDRAILS MESSAGE THAT THE INFUSION EXCEEDED THE LIMIT OF 2000 UNITS/HOUR AND SELECTED TO PROCEED WITH THE INFUSION. RATE ACCURACY TESTING OF THE PUMP MODULE FOUND THE MODULE WAS INFUSING WITHIN SPECIFICATIONS. THE ROOT CAUSE FOR THE REPORTED OVER INFUSION OF HEPARIN IS DUE TO USER PROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HEPARIN INFUSION 25,000 UNITS IN 500MLS OF SOLUTION FOUND RUNNING AT THE WRONG DOSE. THE INTENDED PROGRAMMING WAS 2250 UNITS/HOUR. THE DEVICE WAS FOUND RUNNING AT 2550 UNITS/HOUR. THE NURSE REPORTED THE PROGRAMMING CHANGED ON ITS OWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)