BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-PRIZM VIP AMBULATORY INFUSION PUMP

    MDR report key: 1163060 · Received September 15, 2008

    Report

    Report Number
    2183502-2008-00262
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 16, 2008
    Report Date
    September 15, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    IN 2008, A MEDICATION CASSETTE RESERVOIR CONTAINING 100ML OF HYDROMORPHONE (200 MG) WAS INSTALLED ON THE SUSPECT MEDICAL DEVICE AND PLACED ON THE PATIENT (THE RATE IS UNKNOWN). AT APPROXIMATELY 3 DAYS LATER; PER THE PUMP'S DISPLAY 64.9 ML SHOULD HAVE BEEN REMAINING IN THE RESERVOIR BUT THE CASSETTE WAS EMPTY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE POSSIBILITY OF NARCOTIC OVERINFUSION. THE PATIENT WAS RELEASED AND PLACED BACK ON TO A PCA PUMP. THE PUMP WILL BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-PRIZM VIP AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) 6101 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention