BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60- PUMP

    MDR report key: 9995195 · Received April 23, 2020

    Report

    Report Number
    MW5094258
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 14, 2020
    Report Date
    April 15, 2020
    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

    INDICATION: OTHER COMMON VARIABLE IMMUNODEFICIENCIES; PATIENT REPORTED THAT SHE WAS NOT ABLE TO INFUSE HIZENTRA DUE TO SPRING ON PUMP BROKE: PHARMACY SHIPPED NEW PUMP TO PATIENT ON 04/15/2020 AND PUMP IS AVAILABLE FOR RETURN (RETURN BOX WAS ALSO SENT TO PATIENT), BUT PUMP'S SERIAL NUMBER WAS NOT REPORTED; PATIENT MISSED DOSE DUE TO BEING UNABLE TO INFUSE, BUT NO ADVERSE EVENT REPORTED DUE TO MISSED DOSE; PATIENT STATED SHE HAS ENOUGH MEDICATION FROM PREVIOUS SHIPMENTS AND JUST NEEDS THE NEW PUMP. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457624 FREEDOM 60- PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR