BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60-PUMP

    MDR report key: 10770302 · Received October 30, 2020

    Report

    Report Number
    MW5097588
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 12, 2020
    Manufacturer
    REPRO-MED SYSTEMS, INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS; CALL PATIENT STATED AFTER HIS LAST INFUSION WEDNESDAY THE PUMP BROKE AND IS NOT WORKING PROPERTY, DID NOT REPORT ANY SPECIFIC DETAILS. PT DID NOT MISS A DOSE; NO ADVERSE EVENT REPORTED; UNKNOWN IF DEVICE AVAILABLE FOR RETURN; UNKNOWN LOT/EXPIRATION. START DATE UNKNOWN BECAUSE PT WAS RECEIVING FROM (B)(6) BEFORE (AND LIKELY HAD A PUMP FROM THEM - WE HAVE NEVER SHIPPED A PUMP TO THE PATIENT). NO FURTHER INFO, OR DATES KNOWN. PUMP USED TO INFUSE HIZENTRA 20% 11 GRAMS SUBCUTANEOUSLY WEEKLY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231682 FREEDOM 60-PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR