BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD PRIZM

    MDR report key: 334360 · Received May 21, 2001

    Report

    Report Number
    334360
    Event Type
    Injury
    Date Received
    May 21, 2001
    Date of Event
    April 6, 2001
    Report Date
    April 30, 2001
    Manufacturer
    SIMS MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    1 DAY PRIOR TO EVENT DATE: PTS SPONSE CONCERNED WITH THEIR WT LOSS OF 4#. 4 DAYS AFTER EVENT DATE: POSSIBLE UNDER INFUSION OF PTS TPN AND HYO THERAPIES NOTED. 10 DAYS AFTER EVENT DATE: MD HAS INCREASED AMINO ACIDS & DEXTROSE CONC'S TO COUNTERACT WT. 11 DAYS AFTER EVENT DATE: PT'S SPOUSE IS PHYSICALLY MEASURING RESIDUALS OF BOTH TPN/HYO-TPN RESIDUALS UP TO 600ML YET PUMP SLOWS CORRECT AMOUNT INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23802 CAPD PRIZM AMBULATORY INFUSION PUMP FRN SIMS MEDICAL SYSTEMS CAPD PRIZM *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention