BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12672516 · Received October 20, 2021

    Report

    Report Number
    MW5104815
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Report Date
    October 15, 2021
    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: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PATIENT STATES THAT HIS PUMP IS NOT WORKING. HE WAS 90% COMPLETE WITH HIS INFUSION WHEN HE HEARD A POP AND THE PUMP BROKE AND HE FINISHED THE REMAINDER MANUALLY. HE STATED THE BLACK LEVER DOES NOT GO BACK ANYMORE. NO MISSED DOSE. NO ADE REPORTED; AVAILABLE FOR RETURN; UNKNOWN LOT/EXPIRATION. NO FURTHER INFORMATION KNOWN. PUMP USED TO INFUSE HIZENTRA 20 % AT ABOVE DOSE AND FREQUENCY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566883 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1