BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 PUMP

    MDR report key: 19751298 · Received July 15, 2024

    Report

    Report Number
    MW5157301
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Report Date
    July 9, 2024
    Manufacturer
    KORU/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 COMMUNICATION FROM PATIENT WHO REPORTED SHE NOTICED 2 WEEKS AGO THAT PUMP SEEMED TO BE JAMMING, NOT ALLOWING FLUID TO PASS INTO THE TUBING AND WAS ONLY SUCCESSFUL WITH 95% OF THE INFUSION. DURING THE LAST INFUSION, THERE WAS NO JAMMING BUT THE INFUSION TOOK TWICE AS LONG BUT WAS SUCCESSFUL WITH COMPLETION. MD UNAWARE. DEFECTIVE PUMP SERIAL NUMBER UNKNOWN. MAINTENANCE DUE DATE UNKNOWN. PRODUCT AVAILABLE FOR RETURN. NO ADVERSE EVENTS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. THE SUSPECT DEVICE SERIAL NUMBER WAS NOT PROVIDED BY THE PATIENT. THE FOLLOWING DEVICE SERIAL NUMBERS ARE CURRENTLY CHECKED OUT BY THE PATIENT FOR USE: (B)(6). REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748108 FREEDOM60 PUMP PUMP, INFUSION FRN KORU/REPRO MED SYSTEMS, INC. F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female HIZENTRA 20% PFS (4GM TOTAL).