BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3063775 · Received April 3, 2013

    Report

    Report Number
    2016493-2013-00173
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF MIDAZOLAM. STATED THE INTENDED PROGRAMMING WAS FOR MIDAZOLAM 100MG/100ML AT 8MG/HR. THE CUSTOMER STATED THE CCU PROFILE AND GUARDRAILS DRUG MIDAZOLAM 100MG/100ML WERE SELECTED. THE DOSE OF 8MG/HR WAS ENTERED, A "LOW CONCENTRATION" GUARDRAILS ALERT OCCURRED, WAS ACKNOWLEDGED AND THE INFUSION STARTED. THE INFUSION WAS STARTED AT 09:00AM AND BY 10:00AM, THE 100ML BAG WAS ALMOST EMPTY. THE PT WAS INTUBATED AT THE TIME OF THE EVENT. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE PT WAS TRANSFERRED FROM THE ED TO THE ICU AND REMAINS IN THE ICU AS OF (B)(6) 2013. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137388 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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