BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 18205051 · Received November 22, 2023

    Report

    Report Number
    MW5148472
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Report Date
    November 15, 2023
    Manufacturer
    RMS MEDICAL/ KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDICATION: SELECTIVE DEFICIENCY OF IMMUNOGLOBULING [LGG] SUBCLASSES; SPONTANEOUS REPORT. PATIENT REPORTS FREEDOM PUMP SN (B)(6). INTERNAL MECHANISM SPRING NOT WAKING. JUST A TICKING NOISE THAT WASN'T THERE BEFORE. NO OTHER INFCL'MATION KNOWN. NO MISSED DOSE OR ADVERSE EVENT REPORTED. PUMP WILL BE RETURNED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232239 FREEDOM 60 PUMP PUMP, INFUSION FRN RMS MEDICAL/ KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DIPHENHYDRAMINE| GAMMAGARD