BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP FREEDOM 60

    MDR report key: 9967256 · Received April 15, 2020

    Report

    Report Number
    MW5094150
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    April 11, 2020
    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

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED LAST INFUSION TOOK A REALLY LONG TIME TO INFUSE AND THE LAST 10 ML'S WERE MANUALLY PUSHED. FORGOT TO CALL IN TIME TO GET A REPLACEMENT PUMP OUT TO THEM. PATIENT HAS THE FLU AND HAS NOT INFUSED FOR ABOUT THREE WEEKS. SOLICITED CALL. PUMP LOT NUMBER AND EXPIRATION DATE UNKNOWN. NO ADDITIONAL INFORMATION. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS AND MYASTHENIA GRAVIS WITH (ACUTE) EXACERBATION. FROM (B)(6) 2019 TO CURRENT. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429543 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1