BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 13258052 · Received January 13, 2022

    Report

    Report Number
    MW5106674
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Report Date
    December 7, 2021
    Manufacturer
    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 THE PATIENT'S FATHER WHO REPORTED THAT THE PATIENT'S HIZENTRA INFUSIONS ARE TAKING A MUCH LONGER TIME NOW (ALMOST 5 HOURS), WHEN THEY SHOULD ONLY TAKE 2.5 TO 3 HOURS. THE PHARMACIST APPROVED A NEW FREEDOM PUMP TO BE SHIPPED OUT AS A REPLACEMENT DUE TO POTENTIAL DEFECT IN THE PUMP. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT LOT NUMBER AND EXPIRATION DATE OR SERIAL NUMBER ARE UNKNOWN. IT IS UNKNOWN IF THE PATIENT MISSED ANY DOSES AND/OR EXPERIENCED AN ADVERSE EVENT AS A RESULT OF THE PRODUCT COMPLAINT. THE PUMP RETURN BOX IS BEING SENT TO PATIENT. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122672 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male HIZENTRA