BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM PUMP

    MDR report key: 10690063 · Received October 15, 2020

    Report

    Report Number
    MW5097265
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 10, 2020
    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

    Narratives

    Description of Event or Problem · 1

    PT TRIED TO INFUSE ON (B)(6) 2020 BUT THE SYRINGE FLEW OUT "LIKE A BOW AND ARROW". RPH ADVISED THAT THE LUER DISC WAS PROBABLY NOT SECURELY PLACED INTO THE PUMP PROPERLY OR NOT EVEN ATTACHED WHICH CAUSED THE SYRINGE TO FLY OUT OF THE PUMP WHEN PUMP TURNED ON. PT RECEIVED NEW PUMP TODAY AND STATES WHEN WINDING IT, THE BLACK LEVER WAS NOT GOING BACK. REPLACEMENT PUMP IS BROKEN AS WELL. RPH ADVISED WILL HAVE TEAM MEMBERS CALL PT ON MONDAY TO RESHIP FOR TUESDAY FOR REPLACEMENT DOSE AND PUMP. PT REPORTED SWELLING IN LOWER EXTREMITIES - ADVISED THAT DR AWARE, NO HEART ISSUES AND THAT THEY RECENTLY DID BLOOD WORK AND KIDNEY LEVELS NOT ABNORMAL. COUNSELED THAT ELEVATION COMPRESSION STOCKINGS CAN HELP BUT IF NOTICE ANYTHING GETTING WORSE TO CONSULT MD AGAIN AND BE SURE THAT KIDNEY FUNCTION IS REGULARLY MONITORED. NO FURTHER INFO PROVIDED. INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146488 FREEDOM PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    1146489 FREEDOM PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR