BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 - PUMP

    MDR report key: 10061397 · Received May 14, 2020

    Report

    Report Number
    MW5094516
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Report Date
    May 12, 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 CALL, PT HAD ISSUES WITH PUMP; SHE WAS DONE INFUSING FIRST SYRINGE. PT DISCONNECTED FIRST SYRINGE, CHANGED TO SECOND SYRINGE. PLACED SYRINGE INTO PUMP. WHEN SHE STARTED THE PUMP, THE PLUNGER WENT ALL THE WAY TO THE FRONT OF THE SYRINGE AND MEDICATION CAME OUT OF THE BACK OF THE PLUNGER. PT HAS ANOTHER VIAL AND PUMP TO INFUSE THE REST OF TODAY'S DOSE. NO SIDE EFFECTS REPORTED; NO MISSED DOSE; UNKNOWN IF PUMP AVAILABLE FOR RETURN. LOT UNKNOWN. INDICATION - COMMON VARIABLE IMMUNODEFICIENCY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518422 FREEDOM 60 - PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1