BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14357362 · Received May 10, 2022

    Report

    Report Number
    MW5109616
    Event Type
    Injury
    Date Received
    May 10, 2022
    Report Date
    May 5, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT'S MOTHER REPORTS THAT PT SHOULD BE INFUSING 10 GM OF HIZENTRA EVERY 2 WEEKS, NOT 8 GM, AND PT HAS BEEN GETTING SICK DUE TO NOT GETTING ENOUGH MED; NO DETAILS PROVIDED. PHARMACY HAS NEW RX ON FILE FOR HIZENTRA 8 GM EVERY WEEK, WILL CONTACT MD'S OFFICE TO DISCUSS DOSING AND OBTAIN NEW RX. PT'S MOTHER ALSO REPORTED THAT IT IS TAKING 2.5 HOURS TO INFUSE MED BUT WHEN RPH DID THE CALCULATIONS, INFUSION SHOULD TAKE ONLY 1 HOUR AND 5 MINUTES. PHARMACY WILL REPLACE PUMP AND MOTHER WILL LET PHARMACY KNOW IF DIFFERENT NEEDLE SET AND TUBING REQUIRED. NO FURTHER INFO, DETAILS OR DATES AVAILABLE. INDICATIONS: HEREDITARY HYPOGAMMAGLOBULINEMIA; DRAVET SYNDROME, INTRACTABLE, WITHOUT STATUS EPILEPTICUS; OTHER GENERALIZED EPILEPSY AND EPILEPTIC SYNDROMES, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870946 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male HIZENTRA