BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD - PRIZM VIP

    MDR report key: 1186280 · Received October 2, 2008

    Report

    Report Number
    MW5008524
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    SIMS DELETEC, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CADD-PRIZM VIP MODEL 6101 AMBULATORY INFUSION PUMP, SOFTWARE MODEL: POG IOD COC TOE, MANUFACTURED BY SIMS DELTEC, INC. WAS USED FOR A 46 HOUR CONTINUOUS INFUSION OF CHEMOTHERAPY. THE PUMP CAUSED AIR BUBBLES IN ADDITION TO THE LIQUID TO BE DELIVERED TO THE PT. UPON COMPLAINT, WE WERE TOLD THAT A BUBBLE DETECTOR WAS AVAILABLE, BUT THAT IT WAS COMMONLY REJECTED BY PATIENTS BECAUSE IT GAVE ALARMS ALL TOO OFTEN FOR VERY MINOR BUBBLES. AIR BUBBLES WERE SEEN IN THE TUBING LEADING TO THE PT ON THREE DIFFERENT OCCASIONS WHEN THE PUMP WAS IN USE. WE STOPPED THE PUMP BEFORE THE BUBBLES GAINED ACCESS TO THE PT. WE ARE NOT AWARE OF HARM HAVING BEEN CAUSED BY THE BUBBLES. HOWEVER, THERE IS CLEARLY THE POTENTIAL FOR GRAVE HARM SECONDARY TO AIR BEING INJECTED INTO THE VENOUS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD - PRIZM VIP AMBULATORY INFUSION PUMP FRN SIMS DELETEC, INC. 6101

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability