BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM 60 SQ PUMP

    MDR report key: 14854342 · Received June 28, 2022

    Report

    Report Number
    MW5110568
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INBOUND CALL FROM PHARMACY SERVICE REPRESENTATIVE - SPOKE WITH PATIENT - SAID HER SYRINGE JUMPED OUT OF THE PUMP WITH HER LAST INFUSION, REVIEWED TECHNIQUE FOR SC INFUSION AND LOADING SYRINGE/ TUBING, CORRECTLY ON PUMP. PT. ALSO HAS AN OLD PUMP ON HAND THAT WORKS WELL - AND SHE WILL USE THAT UNTIL WE SEND REPLACEMENT PUMP TO HER. PT THINKS USING OLD PUMP - CAUSING HER TO HAVE KNOTS LIKE REACTION AFTER INFUSION AND SWITCHING TO NEW PUMP MAY HELP. INFORMED PT TO CONTACT US IF ISSUE IS NOT RESOLVED WITH NEXT REFILL. WARM TRANSFER PT TO SPEAK WITH PHARMACY SERVICE REPRESENTATIVE -TO SEND REPLACEMENT FREEDOM 60 PUMP AND TO MAKE AN ARRANGEMENT TO PICK UP OLD PUMP FROM HOME. (ENTERED NOTE PER TEXT NOTE FROM RPH). INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474085 FREEDOM 60 SQ PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F140050

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female