BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3170896 · Received June 5, 2013

    Report

    Report Number
    2016493-2013-00269
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT OF A RATE CHANGE WAS CONFIRMED. A REVIEW OF THE LIMITED INFORMATION CONTAINED IN THE PUMP MODULE'S EVENT LOG INDICATES THAT THE MODULE WAS INITIALLY PROGRAMMED TO INFUSE AT A FLOW RATE OF 0.1 ML/HR AT 1:51 PM ON (B)(6) 2013. ACCORDING TO THE LOG, THE RATE WAS LATER INCREASED TO 0.2 ML/HR AND WAS RUNNING AT THAT RATE WHEN IT WAS CHANGED TO 1.0 ML/HR AT 7:07 PM. FIVE MINUTES LATER, THE RATE WAS CHANGED BACK TO 0.2 ML/HR AND THEN INCREASED TO 2.0 ML/HR AT 10:52 PM THAT EVENING. THE MODULE THEN RAN UNTIL 11:32 PM WHEN IT ALARMED FOR INFUSION COMPLETE-KVO. THE RATE WAS THEN CHANGED BACK TO 0.2 ML/HR AND THE INFUSION CONTINUED UNTIL 6:20 AM THE FOLLOWING DAY WITH NO ADDITIONAL RATE CHANGES. SPECIFIC DETAILS SUCH AS THE DRUG NAME AND CONCENTRATIONS CANNOT BE DETERMINED FROM THE PUMP MODULE EVENT LOG SINCE THIS INFORMATION WOULD BE CONTAINED IN THE ASSOCIATED PCU EVENT LOG WHICH WAS NOT RETURNED. VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE NOTED. FUNCTIONAL TESTING ON THE PUMP MODULE FOUND IT TO BE DELIVERING FLUID WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS DETERMINED TO BE DUE TO USERS PROGRAMMING CHANGE. NO DEVICE MALFUNCTION IS BELIEVED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RATE FOR A MIDAZOLAM INFUSION CHANGED. MIDAZOLAM WAS PROGRAMMED AT 0.2 MG/HR. DURING A CHECK AT 22:45, THE RATE WAS FOUND AT 2 MG/HR. THE TUBING WAS DISCARDED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249598 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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