BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2081311 · Received April 27, 2011

    Report

    Report Number
    2016493-2011-00274
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 31, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PC UNIT EVENT LOGS WERE RECEIVED AND REVIEWED. METHOD - LOG REVIEW. RESULTS - PROGRAMMING ERROR. ON (B)(6) 2011 AT 4:24 AM, THE PC UNIT WAS POWERED ON WITH THREE PUMP MODULES ATTACHED. THE ADULT ICU PROFILE WAS USED AND A MAINTENANCE FLUID WAS IMMEDIATELY STARTED ON ONE OF THE CHANNELS. AT 4:26 AM, THE EVENT PUMP MODULE WAS ACCESSED AND MIDAZOLAM WAS SELECTED FROM THE GUARDRAILS DRUG LIBRARY. TWO DOSING OPTIONS WERE AVAILABLE FOR MIDAZOLAM, WEIGHT BASED DOSING OPTION AND ENTERED A PATIENT (B)(6). THE USER THEN ENTERED A DOSE OF 5 (MG/KG/H) AND A VOLUME TO BE INFUSED (VTBI) OF 50 ML. THE FLOW RATE WAS CALCULATED AT 450 ML/HR. AFTER CONFIRMING THESE PARAMETERS, AND ATTEMPTING TO START THE INFUSION, THE USER RECEIVED A GUARDRAILS WARNING: "DOSE EXCEEDS GUARDRAILS LIMIT OF 0.21 MG/KG/H. PROCEED?" THE USER SELECTED THE YES AND THE INFUSION BEGAN. AT 4:31 AM, THE MIDAZOLAM INFUSION WAS STOPPED AFTER DELIVERING AT TOTAL OF 39.5 ML. AT 4:32 AM, THE EVENT PUMP MODULE WAS ACCESSED AND MIDAZOLAM WAS SELECTED FROM THE GUARDRAILS DRUG LIBRARY. THE USER AGAIN SELECTED THE WEIGHT BASED DOSING OPTION AND ENTERED THE RATE OF 2 ML/HR AND A NEW VTBI OF 30 ML. THE DOSE WAS CALCULATED AT 0.022 MG/KG/H. THE INFUSION WAS STARTED WITH NO GUARDRAIL WARNINGS. THIS INFUSION RAN FOR ABOUT 20 SECONDS BEFORE IT WAS STOPPED. THE REPORTED OVER INFUSION WAS CONFIRMED AND THE ROOT CAUSE WAS IDENTIFIED AS USER PROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED AN EVENT LOG REVIEW TO DETERMINE HOW LONG MIDAZOLAM HAD INFUSED AT 450 ML/HR ON A POST SURGICAL, INTUBATED PATIENT. WHEN THE PATIENT WAS TRANSFERRED FROM THE SURGICAL GURNEY ONTO THE ICU BED, THE IV SET WAS REMOVED FROM THE PUMP MODULE. ONCE THE PATIENT WAS IN THE ICU BED, THE IV SET WAS PLACED BACK INTO THE PUMP MODULE AND THE MIDAZOLAM INFUSION RESTARTED AT 5 MG/KG/HR (PATIENT WEIGHT 90 KG) INSTEAD OF THE INTENDED 5 MG/HR. THE PATIENT REMAINED INTUBATED AND UNRESPONSIVE LONGER THAN EXPECTED FOLLOWING SURGERY. THE CUSTOMER ATTRIBUTED THE PATIENT'S EXTENDED UNRESPONSIVENESS TO THE MIDAZOLAM OVER INFUSION EVENT. THE PATIENT'S VITAL SIGNS REMAINED STABLE AND THE PATIENT RECOVERED WITHOUT ANY ADVERSE SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)| ALARIS PC UNIT: (B)(4)