BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 17436841 · Received July 31, 2023

    Report

    Report Number
    MW5120439
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    June 22, 2023
    Manufacturer
    REPRO-MED 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

    SPONTANEOUS REPORT FROM PT WHO STATED SHE'S HAVING ISSUES WITH HER PUMP AND NEEDS A REPLACEMENT. PT REPORTS THAT THEIR FREEDOM PUMP WAS INFUSING TOO SLOWLY AND HAVING TROUBLE WITH HIZENTRA INFUSION. UNKNOWN IF PT MISSED DOSE OR HAD AN ADVERSE EVENT. UNKNOWN IF PT HAS DEFECTIVE DEVICE FOR RETURN. INDICATION: OTHER COMMON VARIABLE IMMUNODEFICIENCIES; OTHER IMMUNODEFICIENCIES WITH PREDOMINANTLY ANTIBODY DEFECTS; IMMUNODEFICIENCY WITH PREDOMINANTLY ANTIBODY DEFECTS, UNSPECIFIED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773299 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female HIZENTRA