BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14084338 · Received April 11, 2022

    Report

    Report Number
    MW5108890
    Event Type
    Injury
    Date Received
    April 11, 2022
    Report Date
    April 1, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT PUMP WAS NOT FUNCTIONING PROPERLY- STATED THAT HE IS UNABLE TO LOAD THE PREPARED SYRINGE. NEW PUMP SENT TO PATIENT. UNKNOWN IF DOSES OF HIZENTRA WERE MISSED DUE TO PUMP MALFUNCTION. NO ADVERSE EVENT REPORT. UNKNOWN IF MD IS AWARE. SERIAL NUMBER NOT PROVIDED. PUMP IS TO BE RETURNED TO PHARMACY. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788455 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male