BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12659171 · Received October 18, 2021

    Report

    Report Number
    MW5104715
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    October 5, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL PATIENT REPORTS FREEDOM PUMP IS MAKING A TICKING NOISE AND SOUNDS LIKE IT WILL STOP FUNCTIONING. PATIENT STATES HE'S HAD THE SAME PUMP FOR ABOUT 2 YEARS. NEW PUMP BEING SENT TO PATIENT. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED, OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC). NONFAMILIAL HYPOGAMMAGLOBULINEMIA. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550158 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1