BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12696986 · Received October 25, 2021

    Report

    Report Number
    MW5104930
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    March 11, 2021
    Report Date
    March 12, 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

    PATIENT HAD A MALFUNCTION DURING HER INFUSION LAST NIGHT. SHE ONLY GOT ABOUT 3/4 OF HER DOSE. SHE IS FEELING FINE. RPH ADVISED TO CONTACT MD IF SHE HAS ANY FLARES OR PROBLEMS. PATIENT UNDERSTANDS. A MESSAGE WAS LEFT FOR MD OFFICE TO NOTIFY THEM. DID THE PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? PATIENT ONLY GOT ABOUT 3/4 OF HER DOSE BUT SHE IS FEELING FINE. NO MEDICAL INTERVENTION PROVIDED; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DEVICE IS BEING RETURNED DID WE REPLACE THE DEVICE? YES; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? UNKNOWN; WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? ONLY 3/4. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592265 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR