BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14854366 · Received June 28, 2022

    Report

    Report Number
    MW5110569
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Report Date
    June 23, 2022
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S HOME HEALTH NURSE (B)(6) REPORTED DURING CONSULTATION REGARDING CHANGE IN TUBING FOR PATIENT'S HIZENTRA THAT THE FREEDOM PUMP THAT PATIENT HAS ON HAND IS RUNNING SLOWER AND THE INFUSIONS ARE TAKING LONGER TIME THAN THEY USED TO AND THAN THEY SHOULD BE. PHARMACIST APPROVED A REPLACEMENT PUMP TO BE SENT TO THE PATIENT DUE TO THE PUMP MALFUNCTION AND TAKING A LONGER TIME. HOME HEALTH NURSE WILL HAVE PATIENT'S PARENT SEND BACK THE OLD PUMP WHEN REPLACEMENT IS RECEIVED. NO FURTHER INFORMATION PROVIDED, UNKNOWN IF THE REPORTED PRODUCT FAULT OCCURRED WHILE IN USE WITH THE PATIENT. UNKNOWN IF THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO PATIENT OR CLINICAL INJURY. UNKNOWN IF THE ACTUAL DEVICE IS AVAILABLE FOR INVESTIGATION. DEVICE REPLACED BY PHARMACY. UNKNOWN IF THE PATIENT HAD A BACKUP DEVICE THAT SHE WAS ABLE TO SWITCH TO. REPORTED TO CVS/CAREMARK BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474087 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 Female