BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PRIZM PCS II

    MDR report key: 2021573 · Received March 2, 2011

    Report

    Report Number
    2021573
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE RECOVERY ROOM POST SURGICAL PROCEDURE. THE PATIENT STATES PAIN LEVEL OF 10/10 DESPITE MULTIPLE PAIN MEDICATIONS GIVEN. THE PATIENT WAS NOW REQUIRING OXYGEN VIA NASAL CANNULA AT 3 LITERS PER MINUTES. THE PATIENT WAS MOSTLY SLEEPING, BUT AWAKENS, STARTS MOANING AND THEN FALLS RIGHT BACK TO SLEEP. THE PATIENT WILL ALSO OCCASIONALLY UTILIZE PCA BUTTON. THE PCA PUMP WAS EXAMINED AND SHOWED A "RES VOL" OF 4.38ML DILAUDID WHEN THE BAG HAD 58ML REMAINING. THE NURSE CONCLUDED THAT THE PUMP WAS NOT WORKING CORRECTLY AND WAS UNDER INFUSING. THE PUMP WAS PULLED FROM SERVICE AND A NEW PUMP WAS ORDERED ALONG WITH A NEW BAG OF DILAUDID AND TUBING. THE PUMP WAS SENT TO BIOMEDICAL ENGINEERING AND WAS SHIPPED TO THE MANUFACTURER FOR TESTING.FINDINGS: NO PROBLEMS WERE FOUND WITH THE DELIVERY ACCURACY OF THE PUMP. UNABLE TO VERIFY COMPLAINT. ALLEGED DISCREPANCY BETWEEN AMOUNT OF FLUID REMAINING IN THE BAG (58ML) AND THE DELIVERY AMT AS SHOWN BY PUMP (45.5ML) WOULD BE EXPLAINED IF IT WAS A FILLED 100ML BAG AND NOT FILLED TO 50ML WHICH WAS THE AMT PROGRAMMED INTO THE RES VOL OF THE PUMP. THE PUMP WAS FOUND TO BE OPERATING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PRIZM PCS II PUMP, INFUSION, PCA MEA SMITHS MEDICAL PCS II *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR