BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 50

    MDR report key: 11663915 · Received April 13, 2021

    Report

    Report Number
    MW5100754
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 7, 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 FROM PATIENT TO REQUEST A PUMP REPLACEMENT AND ONE MAKE UP DOSE. PER PATIENT THE FREEDOM PUMP FAILED TO WORK LAST NIGHT WHEN TRYING TO SELF INFUSE, THE BACK STOPPER FAILED TO ADVANCE FORWARD AND DID NOT PUSH THE PLUNGER FORWARD. DID THE PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? UNKNOWN; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE THE DEVICE? YES; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? UNKNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555355 PUMP FREEDOM 50 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR