BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 13059777 · Received December 20, 2021

    Report

    Report Number
    MW5106191
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    December 4, 2021
    Report Date
    December 6, 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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS COMMUNICATION FROM THE PATIENT'S MOM WHO REPORTED THAT THE PATIENT MISSED A DOSE ON (B)(6) 2021 DUE TO THE PUMP NOT WORKING CORRECTLY. THE PATIENT'S MOM REPORTED THAT THE PUMP WAS TURNING OFF BEFORE THE FULL DOSE COULD BE ADMINISTERED. NO OTHER DETAILS WERE GIVEN. THE PATIENT DID MISS A DOSE AND NO ADVERSE DRUG EVENT WAS REPORTED. THE DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. IT IS UNKNOWN IF THE MD IS AWARE. THE PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. 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
    1946461 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male