BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 - PUMP

    MDR report key: 10069667 · Received May 18, 2020

    Report

    Report Number
    MW5094537
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Report Date
    May 7, 2020
    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 INBOUND CALL FROM PATIENT STATING THAT PUMP MALFUNCTIONED AND WAS NOT ABLE TO LOAD SYRINGE IN PUMP, SPRING WOULD NOT LOCK IN PLACE. PHARMACIST ADVISED WILL NEED REPLACING. PATIENT ALSO NEEDED MAKEUP DOSE, ALREADY DREW UP HIZENTRA INTO SYRINGE BUT DID NOT INFUSE. NO ADVERSE EVENTS REPORTED FROM THIS MALFUNCTION. DRUG AND PUMP REPLACED. NO OTHER INFORMATION OBTAINED. INDICATION - NONFAMILIAL HYPOGAMMAGLOBULINEMIA AND IMMUNODEFICIENCY, UNSPECIFIED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531981 FREEDOM 60 - PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1