BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 220863 · Received April 16, 1999

    Report

    Report Number
    220863
    Event Type
    Injury
    Date Received
    April 16, 1999
    Date of Event
    March 8, 1999
    Report Date
    March 26, 1999
    Manufacturer
    *
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PRESCRIBED DOBUTAMINE 5 MCG 1 KG/MIN TURN OVER 5 HRS EVERY MON AND WED. THE ADMIXTURE RESULTED IN A CAPD PRIZM FLOW RATE EVERY 10.9 ML/HR. WIFE HAD BEEN INDEPENDENTLY CHANGING CASSETTE AND RESTARTING PUMP FOR SEVERAL MONTHS. FOR SOME REASON SHE BECAME CONFUSED AND CHANGED FLOW RATE TO 0.1 ML/HR BY HITTING UP ARROW WHILE PUMP IN LLI. PT REC'D THIS NON THERAPEUTIC DOSE FOR 2 DAYS. HE SUBSEQUENTLY DEVELOPED INCREASED LUNG CONGESTION POSSIBLY DUE TO UPPER RESPIRATORY INFECTION VS CHF DOBUTAMINE INCREASED TO 3 TIMES WEEK SAME DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FRN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention