BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2123497 · Received June 8, 2011

    Report

    Report Number
    2016493-2011-00367
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 7, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 06/08/2011. (B)(4). THE CUSTOMER'S REPORT OF AN OVER INFUSION OF PROPOFOL COULD NOT BE DEFINITIVELY CONFIRMED NOR REPLICATED DURING THE INVESTIGATION. A REVIEW OF THE ASSOCIATED PC UNIT EVENT LOGS FOUND THAT THE DEVICE WAS PROGRAMMED TO INFUSE PROPOFOL WITH THE DOSAGE BEING TITRATED DOWN THROUGHOUT THE TIME PERIOD IN QUESTION WITH THE INFUSION ENDING IN AN AIR-IN-LINE ALARM WITH 26 MLS OF THE STARTING 50 MLS UNACCOUNTED FOR. VISUAL INSPECTION OF THE DEVICE NOTED AN ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PLATEN POST WAS FOUND TO HAVE BEEN BROKEN OFF COMPLETELY. PRIOR INVESTIGATIONS HAVE REVEALED A POTENTIAL FOR CYCLICAL PERIODS OF UNREGULATED FLOW WITH A BROKEN PLATEN POST ON THE PLATEN ASSEMBLY. ADD'L DAMAGE OBSERVED TO THE BEZEL OF THE DEVICE SUGGESTS A FOREIGN OBJECT MAY HAVE BEEN CAUGHT BETWEEN THE DOOR AND PLATEN LEADING TO THE PLATEN POST DAMAGE. TESTING FAILED TO INDUCE THE UNREGULATED FLOW SCENARIO. THE RESULTS OF SEVERAL RATE ACCURACY TESTS ON THE DEVICE, WITH THE DAMAGED PLATEN AND WITH A KNOWN GOOD PLATEN, INDICATE THAT THE DEVICE IS DELIVERING FLUID SLIGHTLY OUT OF THE +/- 5% SPECIFICATIONS. TESTING ALSO INDICATES THAT THE BROKEN PLATEN HAD NO CONTRIBUTORY EFFECT ON THE OUT OF SPECIFICATION CONDITION. THE ROOT CAUSE OF THE CUSTOMER'S REPORTED PROBLEM WAS NOT DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF PROPOFOL. PROPOFOL 20 MCG/KG/MIN (1000MG/100ML) INITIATED AT 1543, AND FOUND TO BE COMPLETELY EMPTY AT 1714. WHEN THE PUMP WAS TOTALLED OUT, THE VOLUME INFUSED SHOWED 75ML (WHICH WAS THE VOLUME FOR A TOTAL OF 4.5 HOURS INCLUDING THE AM). WHEN THE RN CHECKED THE CHANNEL AND PAUSED IT, THE DRIP CHAMBER CONTINUED TO VERY STEADILY DRIP. IT IS ASSUMED THAT THE PT RECEIVED THE ENTIRE BOTTLE OF PROPOFOL. THERE WAS NO INJURY TO THE PT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    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 37 YR ALARIS PC UNIT, S/N (B)(4)| ALARIS PUMP MODULE, S/N (B)(4)| ALARIS PUMP MODULE, S/N (B)(4)| ALARIS PUMP MODULE, S/N (B)(4)