BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM

    MDR report key: 9483902 · Received December 17, 2019

    Report

    Report Number
    1318360-2019-00005
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 24, 2019
    Report Date
    December 17, 2019
    Manufacturer
    REPRO-MED SYSTEMS, INC.
    Product Code
    PKP
    PMA / PMN Number
    K162613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MW 5091360 WAS RECEIVED VIA MAIL. PHARMACIST REPORTED NURSE HAD TROUBLE LOADING THE FREEDOM PUMP FOR INFUSION. THE PATIENT RECEIVED THE ENTIRE INFUSION IN 10 MINUTES. THE PHARMACIST INDICATED THE INFUSION TIME SHOULD HAVE BEEN 90 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279775 INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM PKP REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1