BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12682295 · Received October 21, 2021

    Report

    Report Number
    MW5104887
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 20, 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

    SPONTANEOUS CALL PATIENT REPORTED THAT AFTER COMPLETING HIS HIZENTRA INFUSION LAST NIGHT, THE SPRING IN HIS FREEDOM PUMP WOULD NOT SPRING BACK OR REWIND BACK UP. PATIENT WAS ABLE TO INFUSE HIS ENTIRE DOSE PRIOR TO PUMP MALFUNCTION. PATIENT DOES NOT HAVE ANY BACK-UP PUMP ON HAND. PHARMACIST APPROVED SHIPMENT OF NEW PUMP AND RETURN OF DAMAGED PUMP. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567757 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR