BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PCA MODULE

    MDR report key: 1032490 · Received April 16, 2008

    Report

    Report Number
    2016493-2008-00025
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    REPORTS OVERINFUSION OF HYDROMORPHONE. NURSE STATES THE INFUSION COMPLETED 1 HOUR SOONER THAN EXPECTED. STANDARD CONCENTRATION AND INTENDED DOSE FOR THIS PATIENT WAS HYDROMORPHONE 10 MG/50 ML (200 MCG/ML) WITH A PCA DOSE OF 300 MCG (1.5 ML), PCA DOSE LOCK OUT INTERVAL UNKNOWN. PATIENT RECEIVED MORE HYDROMORPHONE THAN INTENDED. NO MEDICAL INTERVENTION REQUIRED, NO VITAL SIGN CHANGES OR ILL EFFECTS EXPERIENCED BY THE PATIENT. INVESTIGATION: REVIEW OF THE DEVICE LOG SHOWED THE OVERINFUSION WAS A RESULT OF A PROGRAMMING ERROR. THE USER SELECTED THE CUSTOM CONCENTRATION OPTION FROM THE DEVICE MENU, ENTERED 1000 MCG FOR THE DRUG AMOUNT AND 50 ML FOR THE DILUENT AMOUNT, RESULTING IN A CONCENTRATION OF 20 MCG/ML. THE USER THEN PROCEEDED TO RESTORE THE PREVIOUSLY USED PARAMETERS FOR THE PCA ADMINISTRATION OF 300 MCG. THIS PROGRAMMING RESULTED IN A PCA DOSE OF 15 ML OF FLUID. AFTER 3 DOSES AND A PARTIAL FINAL DOSE, THE SYRINGE WAS EMPTY. INFORMATION WAS PROVIDED TO THE CUSTOMER WITH REFERENCE TO ADDING GUARDRAILS DOSING HARD AND SOFT LIMITS IF THE CUSTOMER CONCENTRATION FEATURE WILL BE CONTINUED TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE MEA, PCA INFUSION PUMP MEA CARDINAL HEALTH ALARIS PRODUCTS 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other